Go Article Directory Alabama: 2016

Thursday, 29 September 2016

Nonpiron

Nonpiron may be available in the countries listed below.

Ingredient matches for Nonpiron

Ibuprofen

Ibuprofen is reported as an ingredient of Nonpiron in the following countries:

Peru

International Drug Name Search

Basinal

Basinal may be available in the countries listed below.

Ingredient matches for Basinal

Naltrexone

Naltrexone hydrochloride (a derivative of Naltrexone) is reported as an ingredient of Basinal in the following countries:

Portugal

International Drug Name Search

Tatanol

Tatanol may be available in the countries listed below.

Ingredient matches for Tatanol

Paracetamol

Paracetamol is reported as an ingredient of Tatanol in the following countries:

Vietnam

International Drug Name Search

Dexalgen

Dexalgen may be available in the countries listed below.

Ingredient matches for Dexalgen

Hydroxocobalamin

Hydroxocobalamin is reported as an ingredient of Dexalgen in the following countries:

Brazil

International Drug Name Search

Wednesday, 28 September 2016

Telaren

Telaren may be available in the countries listed below.

Ingredient matches for Telaren

Meloxicam

Meloxicam is reported as an ingredient of Telaren in the following countries:

Peru

International Drug Name Search

Dontisolon

Dontisolon may be available in the countries listed below.

Ingredient matches for Dontisolon

Prednisolone

Prednisolone is reported as an ingredient of Dontisolon in the following countries:

Germany

Prednisolone 21-acetate (a derivative of Prednisolone) is reported as an ingredient of Dontisolon in the following countries:

Germany

International Drug Name Search

Nasalcrom

Generic Name: cromolyn (Nasal route)

KROE-mo-lin

Commonly used brand name(s)

In the U.S.

Nasalcrom

Available Dosage Forms:

Spray

Therapeutic Class: Nasal Agent

Pharmacologic Class: Mast Cell Stabilizer

Uses For Nasalcrom

Cromolyn nasal solution is used to help prevent or treat the symptoms (sneezing, wheezing, runny nose, itching) of seasonal (short-term) or chronic (long-term) allergic rhinitis. Cromolyn powder for nasal inhalation is used to help prevent seasonal (short-term) allergic rhinitis.

This medicine works by acting on certain cells in the body, called mast cells, to prevent them from releasing substances that cause the allergic reaction.

When cromolyn is used to treat chronic (long-term) allergic rhinitis, an antihistamine and/or a nasal decongestant may be used with this medicine, especially during the first few weeks of treatment.

Nasal cromolyn is available without a prescription.

Before Using Nasalcrom

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of nasal cromolyn in children up to 6 years of age (in Canada, up to 5 years of age) with use in other age groups. In older children, this medicine is not expected to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of nasal cromolyn in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Nasalcrom

This medicine usually comes with patient directions. Read them carefully before using the medicine.

Before using this medicine, clear the nasal passages by blowing your nose.

To use:

Cromolyn solution is used with a special spray device.

To keep clean, wipe the nosepiece with a clean tissue and replace the dust cap after use.

To avoid spreading an infection, do not use the container for more than one person.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

In order for this medicine to work properly, it must be used every day in regularly spaced doses as ordered by your doctor:

For patients using cromolyn for seasonal (short-term) allergic rhinitis, up to 1 week may pass before you begin to feel better.

For patients using cromolyn for chronic (long-term) allergic rhinitis, up to 2 to 4 weeks may pass before you feel the full effects of this medicine, although you may begin to feel better after 1 week.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal solution dosage form:
- For allergic rhinitis:
  - Adults and children 6 years of age (in Canada, 5 years of age) and older—One spray into each nostril three to six times a day until condition is better; then, one spray in each nostril every eight to twelve hours.
  - Children up to 6 years of age (in Canada, up to 5 years of age)—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Nasalcrom

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

Nasalcrom Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Allergic reaction (coughing

difficulty in swallowing

hives or itching

swelling of face, lips, or eyelids

wheezing or difficulty in breathing)

nosebleeds

skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, stinging, or irritation inside of nose

flushing

increase in sneezing

Less common

Cough

headache

postnasal drip

unpleasant taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nasalcrom side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nasalcrom resources

Nasalcrom Side Effects (in more detail)
Nasalcrom Use in Pregnancy & Breastfeeding
Nasalcrom Support Group
0 Reviews for Nasalcrom - Add your own review/rating

Nasalcrom nasal Concise Consumer Information (Cerner Multum)

NasalCrom Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nasalcrom with other medications

Hay Fever

Teikason

Teikason may be available in the countries listed below.

Ingredient matches for Teikason

Dexamethasone

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Teikason in the following countries:

Japan

International Drug Name Search

Tavaloxx

Tavaloxx may be available in the countries listed below.

Ingredient matches for Tavaloxx

Levofloxacin

Levofloxacin is reported as an ingredient of Tavaloxx in the following countries:

South Africa

International Drug Name Search

Clobetasol Shampoo

Dosage Form: shampoo
Clobetasol Propionate Shampoo, 0.05% for topical use.

DESCRIPTION:

Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate. It has the following structural formula:

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

Each mL of Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, 0.05%. in a shampoo base consisting of alcohol, citric acid, coco-betaine. polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate

CLINICAL PHARMACOLOGY:

Like other topical corticosteroids, Clobetasol Propionate Shampoo, 0.05%, has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion. Topical corticosteroids can be absorbed from normal intact skin, while inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Due to the fact that circulating levels of corticosteroids are usually below the limit of detection following application, there are no human data regarding the pharmacokinetics of topical corticosteroids. In such cases pharmacodynamic end points, including both hypothalamic-pituitary-adrenal (HPA) axis testing and topical vasoconstriction, are used as surrogates in the assessments of systemic exposure and relative potency, respectively.

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, use of Clobetasol Propionate Shampoo, 0.05%, resulted in demonstrable HPA axis suppression in 5 out of 12 (42%) adolescent patients (see PRECAUTIONS).

Clobetasol Propionate Shampoo is in the super-high range of potency in vasoconstrictor studies.

CLINICAL STUDIES:

The safety and efficacy of Clobetasol Propionate Shampoo, 0.05% has been evaluated in two clinical trials involving 290 patients with moderate to severe scalp psoriasis. In both trials, patients were treated with either Clobetasol Propionate Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in the table below.

	Clobetasol Propionate Shampoo n (%) Study A	Clobetasol Propionate Shampoo n (%) Study B	Clobetasol Propionate Shampoo Vehicle n (%) Study A	Clobetasol Propionate Shampoo Vehicle n (%) Study B
Total Number of Patients	95	99	47	49
Sucess Rate1 at Endpoint2	40 (42.1%)	28 (28.3%)	1 (2.1%)	5 (10.2%)
Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint Erythema3 Scaling3 Plaque Thickening3	17 (17.9%) 21 (22.1%) 35 (36.8%)	12 (12.1% 15 (15.2%) 34 (34.3%)	3 (6.4%) 0 (0%) 5 (10.6%)	1 (2.0%) 2 (4.1%) 5 (10.2%)

1 Success rate defined as the proportion of patients with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician’s Global Severity Scale for scalp psoriasis.

2 At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available).

3 Patients with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale.

Clinical studies of Clobetasol Propionate Shampoo, 0.05% did, not include sufficient numbers of non-Caucasian patients to determine whether they respond differently than Caucasian patients with regards to efficacy and safety.

INDICATIONS AND USAGE:

Clobetasol Propionate Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week (see DOSAGE AND ADMINISRATION).

Patients should be instructed to use Clobetasol Propionate Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS).

Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS, Pediatric Use).

There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.

CONTRAINDICATIONS:

Use of Clobetasol Propionate Shampoo, 0.05%, is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

PRECAUTIONS::

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which increase systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings or use on occluded areas. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

The effect of Clobetasol Propionate Shampoo, 0.05% on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age. In th is study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with Clobetasol Propionate Shampoo, 0.05% applied once daily for 15 minutes to a dry scalp before lathering and rinsing.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (see PRECAUTIONS - Pediatric Use).

If irritation develops, Clobetasol Propionate Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clobetasol Propionate Shampoo should be discontinued until the infection has been adequately controlled.

Although Clobetasol Propionate Shampoo is intended for the topical treatment of moderate to severe scalp psoriasis, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Clobetasol Propionate Shampoo should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

1.         This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.

2.         This medication should not be used for any disorder other than that for which it was prescribed.

3.         The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.

4.         Patients should report any signs of local or systemic adverse reactions to their physician.

5.         As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

6.         Patients should wash their hands after applying the medication.

7.         Patients should inform their physician(s) that they are using Clobetasol Propionate Shampoo if surgery is contemplated.

8.         Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of Clobetasol Propionate Shampoo.

Laboratory tests:

The cortrosyn stimulation test may be helpful in evaluating patients for HPA axis suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate did not produce any increase in chromosomal aberrations in Chinese hamster ovary cells in vitro in the presence or absence of metabolic activation. Clobetasol propionate was also negative in the micronucleus test in mice after oral administration.

Studies of the effect of Clobetasol Propionate Shampoo, 0.05% on fertility have not been conducted.

Pregnancy:

Teratogenic Effects: Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

A teratogenicity study of clobetasol propionate in rats using the dermal route resulted in dose related maternal toxicity and fetal effects from 0.05 to 0.5 mg/kg/day. These doses are approximately 0.1 to 1.0 times, respectively, the maximum human topical dose of clobetasol propionate from Clobetasol Propionate Shampoo. Abnormalities seen included low fetal weights, umbilical herniation, cleft palate, reduced skeletal ossification other skeletal abnormalities.

Clobetasol propionate administered to rats subcutaneously at a dose of 0.1 mg/kg from day 17 of gestation to day 21 postpartum was associated with prolongation of gestation, decreased number of offspring, increased perinatal mortality of offspring, delayed eye opening and delayed hair appearance in surviving offspring. Some increase in offspring perinatal mortality was also observed at a dose of 0.05 mg/kg. Doses of 0.05 and 0.1 mg/kg are approximately 0.1 and 0.2 fold the maximum human topical dose of clobetasol propionate from Clobetasol Propionate Shampoo.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol Propionate Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Shampoo, 0.05%, is administered to a nursing woman.

Pediatric use:

Use of Clobetasol Propionate Shampoo, 0.05%, in patients under 18 years old is not recommended due to potential for HPA axis suppression (see PRECAUTIONS: General).

The effect of Clobetasol Propionate Shampoo, 0.05%, on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age. In this study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with Clobetasol Propionate Shampoo, 0.05%, applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only one of the five subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.

No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing 's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Therefore, use is not recommended in patients under the age of 18.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric use:

Clinical studies of Clobetasol Propionate Shampoo, 0.05%, did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS:

In clinical trials with Clobetasol Propionate Shampoo, the following adverse reactions have been reported: burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.

The table below summarizes selected adverse events that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.

Summary of Selected Adverse Events ≥ 1% by Body System
Body System	Clobetasol Propionate Shampoo N=558	Vehicle Shampoo N=127
Skin and Appendages	49 (8.8%)	28 (22.0%)
Discomfort Skin	26 (4.7%)	16 (12.6%)
Pruritus	3 (0.5%)	9 (7.1%)
Body as a Whole	33 (5.9%)	12 (9.4%)
Headache	10 (1.8%)	1 (0.8%)

The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

OVERDOSAGE:

Topically applied, Clobetasol Propionate Shampoo can be absorbed in sufficient amounts to produce systemic effects. (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Clobetasol Propionate Shampoo should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clobetasol Propionate Shampoo.

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after four weeks of treatment with Clobetasol Propionate Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary. Clobetasol Propionate Shampoo should not be used with occlusive dressings unless directed by a physician.

HOW SUPPLIED:

Clobetasol Propionate Shampoo is supplied in 4 fl.oz. (118 mL) bottles.

NDC 0781-7137-04

Storage:

Keep tightly closed. Store at controlled room temperature 68oF to 77oF (20oC - 25oC).

PATIENT INFORMATION

For External Use Only

Not for Ophthalmic (Eye) Use

Clobetasol Propionate Shampoo, 0.05%

Read the Patient Information that comes with Clobetasol Propionate Shampoo before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Clobetasol Propionate Shampoo?

What is Clobetasol Propionate Shampoo?

Clobetasol Propionate Shampoo is a medicine called a topical (skin use only) corticosteroid. It is used for a short time to treat forms of scalp psoriasis. Clobetasol Propionate Shampoo is a super-high potent (very strong) topical corticosteroid. It is very important that you use Clobetasol Propionate Shampoo only as directed in order to avoid serious side effects.

Who should not use Clobetasol Propionate Shampoo?

Do not use Clobetasol Propionate Shampoo if you are allergic to any of its ingredients, or to any other corticosteroid. The active ingredient is clobetasol propionate. See the end of this leaflet for a complete list of ingredients in Clobetasol Propionate Shampoo. Ask your doctor or pharmacist if you need a list of other corticosteroids.

Clobetasol Propionate Shampoo is not recommended for use by patients under 18 years of age. Children have smaller body sizes and have a higher chance of side effects.

What should I tell my doctor before using Clobetasol Propionate Shampoo?

Tell your doctor:

if you are pregnant, think you are pregnant, plan to be pregnant. Talk with your doctor before using Clobetasol Propionate Shampoo or if you are already using Clobetasol Propionate Shampoo. It is not known if Clobetasol Propionate Shampoo can harm your unborn baby.

if you are breastfeeding. It is not known if Clobetasol Propionate Shampoo passes into your milk, and if it can harm your baby.

if you think you have an infection on your scalp. You may need another medicine to treat the scalp infection before you use Clobetasol Propionate Shampoo.

Tell your doctor about all the other medicines and skin products you use, including prescription and non-prescription medicines, vitamins, herbal supplements, and cosmetics. Some medicines and products can cause serious side effects if used while you are using Clobetasol Propionate Shampoo.

How should I use Clobetasol Propionate Shampoo?

Use Clobetasol Propionate Shampoo exactly as prescribed by your doctor. Clobetasol Propionate Shampoo is for use on your scalp only.

Apply Clobetasol Propionate Shampoo on affected areas of the scalp once a day. Use only enough to cover the affected areas of your scalp. Do not use Clobetasol Propionate Shampoo on your face, groin, armpits, lips, or in your eyes.

Do not wet your hair before using Clobetasol Propionate Shampoo. Move the hair away from the scalp so that one of the affected areas is exposed. Apply a small amount of the shampoo directly onto the affected area by gently squeezing the bottle.Gently, rub Clobetasol Propionate Shampoo into the affected area. Repeat for other affected areas on your scalp.

Do not cover your head with a shower cap or bathing cap while Clobetasol Propionate Shampoo is on your scalp.

Leave Clobetasol Propionate Shampoo in place for 15 minutes before adding water, lathering and rinsing hair and scalp completely. No other shampoos are necessary. However, you can use a non-medicated shampoo on your hair after using Clobetasol Propionate Shampoo if you want to.

Wash your hands after applying Clobetasol Propionate Shampoo. Wash any other part of your body that came into contact with Clobetasol Propionate Shampoo such as your neck and shoulders.

If you forget to apply Clobetasol Propionate Shampoo at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that 1 dose, and continue with your regular schedule. Do not make up the missed dose. If you miss several doses, tell your doctor.

Do not use more than 50 grams (50 mL or 1.75 fluid ounces) of Clobetasol Propionate Shampoo per week.

What should I avoid while using Clobetasol Propionate Shampoo?

Do not do the following while using Clobetasol Propionate Shampoo:

Do not get Clobetasol Propionate Shampoo on your lips or in or near your eyes because this might cause side effects. If you do, use a lot of water to rinse the Clobetasol Propionate Shampoo off your face, lips, or out of your eyes. If your eyes keep stinging after rinsing them well with water, contact your doctor right away.

Do not apply Clobetasol Propionate Shampoo to your face, groin or armpits.

Do not get Clobetasol Propionate Shampoo in your mouth. If you or a child accidentally swallows Clobetasol Propionate Shampoo, call your Poison Control center or local emergency room right away.

Do not cover your head with a shower or bathing cap while Clobetasol Propionate Shampoo is on your scalp.

Do not use Clobetasol Propionate Shampoo any longer than 4 weeks (28 days) for moderate to severe scalp psoriasis.

Do not use more than 50 mL (1.75 fluid ounces) of Clobetasol Propionate Shampoo per week.

What should I do it I miss an application of Clobetasol Propionate Shampoo?

If you forget to apply Clobetasol Propionate Shampoo at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at the time of your next application, apply only one dose and continue with your regular schedule. If you miss several doses, tell your doctor.

What are the possible side effects of Clobetasol Propionate Shampoo?

Clobetasol Propionate Shampoo can pass through your skin. Too much Clobetasol Propionate Shampoo passing through your skin can shut down your adrenal glands. This may happen if you use too much Clobetasol Propionate Shampoo or if you use it for too long, but it can happen with correct use. If your adrenal glands shut down, they may not start working right away after you stop using Clobetasol Propionate Shampoo. Shutting down of the adrenal glands can cause nausea, vomiting, fever, low blood pressure, heart attack and even death because your body cannot adequately respond to stress or illness.

Your doctor may do special blood and urine tests to check your adrenal gland function while you are using Clobetasol Propionate Shampoo.

The most common side effects with Clobetasol Propionate Shampoo include burning or itching at the site of application. Other possible side effects include thinning of the skin and widening of small blood vessels in the skin.

If you go to another doctor for illness, injury or surgery, tell that doctor that you are using Clobetasol Propionate Shampoo.

Tell your doctor if you:

are going to have surgery

get sick or don't feel right. Call your doctor right away.

have irritation of the treated skin area that does not go away

have any unusual effects that you do not understand

have affected areas that do not seem to be healing after 4 weeks of using Clobetasol Propionate Shampoo.

These are not all the possible side effects of Clobetasol Propionate Shampoo. For more information, ask your doctor or pharmacist.

How should I store Clobetasol Propionate Shampoo?

Store Clobetasol Propionate Shampoo at room temperature between 68oF to 77oF (20oC - 25o C).

Keep the bottle tightly closed at all times.

Do not use Clobetasol Propionate Shampoo after the expiration date shown on bottle.

Keep Clobetasol Propionate Shampoo and all medicines out of the reach of children.

General information about Clobetasol Propionate Shampoo

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Clobetasol Propionate Shampoo for a condition for which it was not prescribed. Do not give Clobetasol Propionate Shampoo to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Clobetasol Propionate Shampoo. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobetasol Propionate Shampoo that is written for health professionals.

What are the ingredients in Clobetasol Propionate Shampoo?

Active ingredient: clobetasol propionate

Excipients (shampoo base): alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate and sodium laureth sulfate.

Rx only

Manufactured by:

G Production Inc.

Baie d’Urfé, QC, H9X 3S4 Canada for

Sandoz Inc.

Princeton, NJ 08540

Made in Canada.

P51964-0

Revised: October 2011

CLOBETASOL PROPIONATE
clobetasol propionate shampoo

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-7137
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clobetasol propionate (Clobetasol)	Clobetasol propionate	0.05 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol
citric acid
water
sodium citrate
sodium laureth sulfate

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-7137-04	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		118 mL In 1 BOTTLE	This package is contained within the CARTON (0781-7137-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA021644	12/22/2011

Labeler - Sandoz, Inc. (110342024)

Establishment
Name	Address	ID/FEI	Operations
G Production, Inc.		251676961	manufacture

Revised: 01/2011Sandoz, Inc.

Tegol

Tegol may be available in the countries listed below.

Ingredient matches for Tegol

Carbamazepine

Carbamazepine is reported as an ingredient of Tegol in the following countries:

Taiwan

International Drug Name Search

Allegra

Generic Name: fexofenadine (Oral route)

fex-oh-FEN-a-deen

Commonly used brand name(s)

In the U.S.

Allegra

Allegra ODT

Available Dosage Forms:

Tablet

Tablet, Disintegrating

Capsule

Suspension

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Butyrophenone

Uses For Allegra

Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) .

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some people histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some people to have hives, with severe itching of the skin .

This medicine is available only with your doctor's prescription .

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Allegra

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fexofenadine in children below 6 months of age. Safety and efficacy have not been established .

Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fexofenadine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving fexofenadine .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Droperidol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Apple Juice

Grapefruit Juice

Orange Juice

Proper Use of fexofenadine

This section provides information on the proper use of a number of products that contain fexofenadine. It may not be specific to Allegra. Please read with care.

You should always take this medicine with water. Do not take it with juice such as grapefruit, orange, or apple juice .

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist .

For patients using the oral disintegrating tablet form of this medicine:

Make sure your hands are dry.

Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.

Immediately place the tablet on top of the tongue. Do not chew or break the tablet.

The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved.

Always take this tablet on an empty stomach .

Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup .

Dosing

For symptoms of hay fever:
- For oral dosage form (capsules, tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  - Children 6 to 11 years of age—30 mg two times a day.
  - Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  - Children and infants up to 4 years of age—Use is not recommended .
- For oral dosage form (disintegrating tablets):
  - Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  - Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  - Children and infants up to 4 years of age—Use is not recommended .
- For oral dosage form (suspension):
  - Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  - Children younger than 4 years of age—Use and dose must be determined by your doctor .

For symptoms of chronic hives:
- For oral dosage form (capsules, tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  - Children 4 to 11 years of age—30 mg two times a day.
  - Children younger than 4 years of age—Use and dose must be determined by your doctor .
- For oral dosage form (disintegrating tablets):
  - Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  - Children younger than 4 years of age—Use and dose must be determined by your doctor .
- For oral dosage form (suspension):
  - Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  - Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day.
  - Children younger than 6 months of age—Use and dose must be determined by your doctor .

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Allegra

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects .

Allegra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Chest tightness

feeling of warmth, redness of the face, neck, arms and occasionally, upper chest

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

shortness of breath, difficult or labored breathing

More common

Vomiting

Less common

Back pain

body aches or pain

chills

coughing

diarrhea

difficulty with moving

dizziness

ear congestion

earache

fever

headache

joint pain

loss of voice

muscle aching or cramping

muscle pains or stiffness

nasal congestion

nausea

pain in arms or legs

pain or tenderness around eyes or cheekbones

painful menstrual bleeding

redness or swelling in ear

ringing or buzzing in ears

runny or stuffy nose

sleepiness or unusual drowsiness

sneezing

sore throat

stomach upset

swollen joints

unusual feeling of tiredness or weakness

viral infection (such as cold and flu)

Rare

Nervousness

rash

sleeplessness

terrifying dreams

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Allegra side effects (in more detail)

More Allegra resources

Allegra Side Effects (in more detail)
Allegra Use in Pregnancy & Breastfeeding
Drug Images
Allegra Drug Interactions
Allegra Support Group
21 Reviews for Allegra - Add your own review/rating

Allegra Prescribing Information (FDA)

Allegra Monograph (AHFS DI)

Allegra Consumer Overview

Allegra MedFacts Consumer Leaflet (Wolters Kluwer)

Fexofenadine Prescribing Information (FDA)

Allegra ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Allegra with other medications

Hay Fever
Urticaria

Tuesday, 27 September 2016

Tathion

Tathion may be available in the countries listed below.

Ingredient matches for Tathion

Glutathione

Glutathione is reported as an ingredient of Tathion in the following countries:

Japan

International Drug Name Search

Lyman

Lyman may be available in the countries listed below.

Ingredient matches for Lyman

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Lyman in the following countries:

Switzerland

International Drug Name Search

Teeth-Tough

Teeth-Tough may be available in the countries listed below.

Ingredient matches for Teeth-Tough

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Teeth-Tough in the following countries:

Israel

International Drug Name Search

Prometazina Cloridrato Nova Argentia

Prometazina Cloridrato Nova Argentia may be available in the countries listed below.

Ingredient matches for Prometazina Cloridrato Nova Argentia

Promethazine

Promethazine is reported as an ingredient of Prometazina Cloridrato Nova Argentia in the following countries:

Italy

International Drug Name Search

Taurolidin Nova

Taurolidin Nova may be available in the countries listed below.

Ingredient matches for Taurolidin Nova

Taurolidine

Taurolidine is reported as an ingredient of Taurolidin Nova in the following countries:

Germany

International Drug Name Search

Taro-Warfarin

Taro-Warfarin may be available in the countries listed below.

Ingredient matches for Taro-Warfarin

Warfarin

Warfarin sodium salt (a derivative of Warfarin) is reported as an ingredient of Taro-Warfarin in the following countries:

Canada

International Drug Name Search

Pantoprazole RPG

Pantoprazole RPG may be available in the countries listed below.

Ingredient matches for Pantoprazole RPG

Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantoprazole RPG in the following countries:

France

International Drug Name Search

Tritazide

Tritazide may be available in the countries listed below.

Ingredient matches for Tritazide

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Tritazide in the following countries:

Austria

Belgium

Croatia (Hrvatska)

Netherlands

Slovakia

Slovenia

Tunisia

Ramipril

Ramipril is reported as an ingredient of Tritazide in the following countries:

Austria

Belgium

Croatia (Hrvatska)

Netherlands

Slovakia

Slovenia

Tunisia

International Drug Name Search

Tegrebos

Tegrebos may be available in the countries listed below.

Ingredient matches for Tegrebos

Carbamazepine

Carbamazepine is reported as an ingredient of Tegrebos in the following countries:

Bosnia & Herzegowina

International Drug Name Search

Teedex

Teedex may be available in the countries listed below.

Ingredient matches for Teedex

Diphenhydramine

Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Teedex in the following countries:

Ireland

Paracetamol

Paracetamol is reported as an ingredient of Teedex in the following countries:

Ireland

International Drug Name Search

Tele-Stulln

Tele-Stulln may be available in the countries listed below.

Ingredient matches for Tele-Stulln

Naphazoline

Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Tele-Stulln in the following countries:

Germany

International Drug Name Search

Adcal-D3 Caplets

1. Name Of The Medicinal Product

Adcal-D3 Caplets, 750 mg/200 I.U, film-coated tablets

2. Qualitative And Quantitative Composition

Per tablet:

Calcium carbonate: 750 mg equivalent to 300 mg of elemental calcium.

Colecalciferol: 200 I.U. equivalent to 5 μg vitamin D_3.

This product also contains sucrose (part of the vitamin D₃ concentrate: approximately 0.4 milligrams per tablet).

For full list of excipients see 6.1.

3. Pharmaceutical Form

Pale orange capsule-shaped film-coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

As an adjunct to specific therapy for osteoporosis and in situations requiring therapeutic supplementation of malnutrition e.g. in pregnancy and established vitamin D dependent osteomalacia.

The prevention and treatment of calcium deficiency/vitamin D deficiency especially in the housebound and institutionalised elderly subjects. Deficiency of the active moieties is indicated by raised levels of PTH, lowered 25-hydroxy vitamin D and raised alkaline phosphatase levels which are associated with increased bone loss.

4.2 Posology And Method Of Administration

Oral.

Adults and Elderly and children above 12 years of age:

Two tablets to be taken twice a day, preferably two tablets each morning and two tablets each evening.

Children:

Not recommended for children under 12 years.

4.3 Contraindications

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis, primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

4.4 Special Warnings And Precautions For Use

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary calcium excretion.

In patients with a history of renal stones, urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5 mmol/24 hours (300 mg/24 hours).

Caution is required in patients receiving treatment for cardiovascular disease (see Section 4.5 – thiazide diuretics and cardiac glycosides including digitalis).

Adcal-D3 should also be used with caution in other patients with increased risk of hypercalcaemia e.g. patients with sarcoidosis or those suffering from malignancies.

This product contains small quantities of sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Allowances should be made for calcium and vitamin D supplements from other sources.

Adcal should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary, monitoring of ECG and calcium.

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics and iron. It is advisable to allow a minimum period of four hours before taking calcium.

4.6 Pregnancy And Lactation

During pregnancy and lactation, treatment with Adcal-D3 Caplets should always be under the direction of a physician. Requirements for calcium and vitamin D are increased during pregnancy and lactation, but, in deciding on the required supplementation, allowances should be made for availability of these agents from other sources. If the patient requires administration of both Adcal-D3 Caplets and iron supplements, they should be taken at different times (see Section 4.5).

Overdoses of vitamin D have shown teratogenic effects in pregnant animals. However, there have been no studies on the use of this medicinal product in human pregnancy and lactation. In humans, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin D and its metabolites pass into the breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain or diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia, have been seen with long term treatment at high dosages.

4.9 Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

A12AX01; Calcium carbonate and colecalciferol

Strong evidence that supplemental calcium and vitamin D₃ can reduce the incidence of hip and other non-vertebral fractures derives from an 18 month randomised placebo controlled study in 3270 healthy elderly women living in nursing homes or apartments for elderly people. A positive effect on bone mineral density was also observed.

In patients treated with 1200mg elemental calcium and 800IU vitamin D₃ daily, i.e. the same dose delivered by the twice daily administration of two Adcal-D3 Caplets, the number of hip fractures was 43% lower (p=0.043) and the total number of non vertebral fractures was 32% lower than among those who received placebo. Proximal femur bone mineral density after 18 months of treatment increased 2.7% in the calcium/vitamin D₃ group and decreased 4.6% in the placebo group (p<0.001). In the calcium/vitamin D₃ group, the mean serum PTH concentration decreased by 44% from baseline at 18 months and serum 25-hydroxy-vitamin D concentration had increased by 162% over baseline.

Analysis of the intention-to-treat results showed a decreased probability of both hip fractures (p=0.004) and other fractures (p < 0.001) in the calcium/vitamin D₃ treatment group. Analysis of the other two populations (active treatment and those treated and followed for 18 months) revealed comparable results to the intention-to-treat analysis. The odds ratio for hip fractures among women in the placebo group compared with those in the calcium/vitamin D₃ group was 1.7 (95% CI 1.0 to 2.8) and that for other nonvertebral fractures was 1.4 (95% CI 1.4 to 2.1). In the placebo group, there was a marked increase in the incidence of hip fractures over time whereas the incidence in the calcium/vitamin D₃ group was stable. Thus treatment reduced the age-related risk of fracture at 18 months (p = 0.007 for hip fractures and p = 0.009 for all non-vertebral fractures). At 3 years follow-up, the decrease in fracture risk was maintained in the calcium/vitamin D₃ group.

5.2 Pharmacokinetic Properties

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

The pharmacokinetics of vitamin D is also well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25 dihydroxycholecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α - globin. Vitamin D and its metabolites are excreted mainly in the bile and faeces.

5.3 Preclinical Safety Data

Calcium carbonate and vitamin D are well known and widely used materials and have been used in clinical practice for many years. As such, toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet Core:

Colloidal silicon dioxide

Microcrystalline cellulose

Croscarmellose sodium

Magnesium stearate

Modified food starch

Sucrose

Sodium ascorbate cryst.

Medium chain triglycerides

Silicon dioxide

DL-alpha-tocopherol

Pregelatinized starch

Film-coat:

Hypromellose

Polydextrose

Acacia

Talc

Titanium dioxide

Iron oxide yellow

Iron oxide red

6.2 Incompatibilities

Not applicable, oral preparation.

6.3 Shelf Life

18 months in HDPE bottle.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

HDPE bottle with polyethylene cap and silica gel dessicant: Pack sizes 112 or 224 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special conditions.

7. Marketing Authorisation Holder

ProStrakan Limited

Galabank Business Park

Galashiels

TD1 1QH

8. Marketing Authorisation Number(S)

PL 16508/0039

9. Date Of First Authorisation/Renewal Of The Authorisation

13/07/2011

10. Date Of Revision Of The Text

13/07/2011

LEGAL CATEGORY

Pentazocine Hydrochloride

Class: Opiate Partial Agonists
Note: This monograph also contains information on Pentazocine Lactate
VA Class: CN101
CAS Number: 64024-15-3
Brands: Talacen, Talwin, Talwin Nx

Introduction

Analgesic; synthetic opiate partial agonist.^a

Uses for Pentazocine Hydrochloride

Pain

Relief of moderate to severe pain^a ^b ^c such as that associated with acute and chronic medical disorders including cancer, orthopedic problems, renal or biliary colic, and dental surgery.^a

Preoperative sedation and analgesia and as an adjunct to surgical anesthesia.^a ^c

Obstetric analgesia during labor.^a ^c

Oral dosage form reformulated to contain small amount of naloxone hydrochloride (opiate antagonist) to potentially eliminate misuse via parenteral injection by opiate addicts and drug abusers.^a ^b Naloxone is inactive when administered orally in the amount (0.5 mg) present in the oral formulation and does not affect the efficacy of pentazocine when administered orally.^a ^b

Pentazocine Hydrochloride Dosage and Administration

General

If pentazocine hydrochloride tablets containing small amount of naloxone hydrochloride are ground up and solubilized for parenteral administration, the naloxone will antagonize the effects of pentazocine and will precipitate withdrawal symptoms in drug abusers who are dependent on opiates.^a ^b

Administration

Administer orally or by IV, IM, or sub-Q injection.^b ^c

Oral Administration

Oral administration is preferable to parenteral administration for chronic therapy.^a

IV Administration

For drug compatibility information, see Compatibility under Stability.

IM or Sub-Q Administration

Rotation of injection sites is essential.^c

Administer sub-Q only when necessary, because of possible severe tissue damage at the injection site.^c

Dosage

Available as pentazocine hydrochloride (tablets) and pentazocine lactate (injection); dosage expressed in terms of pentazocine.^a ^c Also available as pentazocine and naloxone hydrochlorides; dosage expressed in terms of the bases.¹⁰⁰ ¹⁰¹

Adjust dosage according to severity of pain, physical status of the patient, and other drugs that the patient is receiving.^a

Pediatric Patients

Pain

Preoperative Sedation

Children 1–16 years of age: 0.5 mg/kg.^c

Adults

Pain

Oral

Initially, 50 mg every 3–4 hours.^a ^b Increase dosage to 100 mg when needed (maximum 600 mg daily).^a ^b

IV, IM, or Sub-Q

Initially, 30 mg; may repeat dose every 3–4 hours as necessary.^a ^c

Obstetric Analgesia

20 mg IV when contractions become regular; may repeat dose 2 or 3 times at intervals of 2–3 hours as needed.^a ^c

30 mg IM as a single dose.^a ^c

Prescribing Limits

Adults

Pain

Oral

Maximum 600 mg daily.^b

IV

Maximum 30 mg as a single dose; maximum 360 mg daily.^c

IM

Maximum 60 mg as a single dose; maximum 360 mg daily.^c

Sub-Q

Maximum 60 mg as a single dose; maximum 360 mg daily.^c

Special Populations

Hepatic Impairment

Doses and/or frequency of administration may need to be decreased, particularly when administered orally, in patients with hepatic impairment (e.g., cirrhosis).¹⁴⁴ ¹⁴⁵ ¹⁵⁵

Geriatric Patients

Cautious dosage selection recommended; initiate therapy at the lower end of the usual range.^b ^c

Cautions for Pentazocine Hydrochloride

Contraindications

Known hypersensitivity to pentazocine or any ingredient in the formulation.^b ^c ^d

Warnings/Precautions

Warnings

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence.¹⁰⁰ ¹⁰⁹ ¹²⁴ ¹²⁵ ¹²⁶ ¹²⁷ ¹²⁸ ¹²⁹ ¹⁶⁵ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁷¹ ¹⁷² ¹⁷³ ¹⁷⁴ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁰ ¹⁸¹ ¹⁸² ¹⁸⁶

Prescribe cautiously for patients who are emotionally unstable or have a history of opiate abuse; closely supervise these patients when therapy for more than 4 or 5 days is contemplated.^a Avoid unnecessary increases in dosage or frequency of administration; avoid use in anticipation of pain.^a

If tablets are ground up and solubilized for parenteral administration, the naloxone will antagonize the effects of pentazocine and can precipitate withdrawal in individuals physically dependent on opiates.¹⁰⁰ ¹⁰⁶ ¹⁶¹ However, since naloxone is inactive when administered orally in the amount present in the tablets, the tablets are still subject to misuse and abuse by the oral route.¹⁰⁰

Pentazocine has been abused in combination with tripelennamine (no longer commercially available in US) (T’s and blues) via parenteral injection by opiate addicts and drug abusers in an attempt to provide effects similar to those of IV heroin.¹⁰⁶ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹² ¹¹³ ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹³⁰ ¹⁸⁶

Local Effects

Possible ulceration and severe sclerosis of the skin, subcutaneous tissues, and underlying muscle following repeated injection.^c Rotation of injection sites is essential.^c

Head Injury and Increased Intracranial Pressure

Potential for elevation of CSF pressure as a result of vasodilation following carbon dioxide retention.^a ^c Opiate effects may obscure the existence, extent, or course of intracranial pathology.^b ^c Use in patients with head injury, other intracranial lesions, or preexisting elevation in intracranial pressure only if the potential benefits justify the possible risks.^a ^b ^c

Patients Dependent on Opiates

Partial opiate antagonist.^b ^c Use with caution in patients who have been chronically receiving opiates (including methadone); pentazocine does not suppress the abstinence syndrome in these patients; high doses may precipitate withdrawal symptoms.^b ^c

Respiratory Effects

Possible respiratory depression (decreased rate and depth of respiration), dyspnea, and laryngospasm.^a ^b

Use with caution and in low doses in patients with impaired respiration caused by other drugs, uremia, or severe infection and in patients with severely limited respiratory reserve, bronchial asthma or other obstructive respiratory conditions, or cyanosis.^b ^c

Pentazocine-induced respiratory depression can be reversed by naloxone.^b

WIthdrawal Effects

Abrupt discontinuance after prolonged use may result in withdrawal symptoms (e.g., abdominal cramps, vomiting, increased temperature, sweating, chills, restlessness, anxiety, lethargy, rhinorrhea, sneezing, lacrimation).¹⁶⁶ ¹⁶⁹ ¹⁷² ¹⁷³ ¹⁷⁴ ¹⁷⁵ ¹⁷⁶ ¹⁸¹ ¹⁸² ¹⁸⁴ ¹⁸⁵ Reinstitution of parenteral pentazocine followed by gradual withdrawal of the drug may ameliorate withdrawal symptoms, if necessary.^c Manufacturer states that substitution of methadone or other opiates to treat pentazocine abstinence syndrome should be avoided;¹⁸⁴ however, opiates occasionally have been used in the management of pentazocine withdrawal;¹⁶⁹ ¹⁷² ¹⁷⁴ ¹⁸² ¹⁸³ benzodiazepines also have been used in a limited number of individuals.¹⁸¹

CNS Depression

Performance of activities requiring mental alertness and physical coordination may be impaired.^b ^c

Concurrent use of other CNS depressants may potentiate CNS depression.^b ^c (See Specific Drugs and Laboratory Tests under Interactions.)

Acute CNS Manifestations

Hallucinations (usually visual), disorientation, and confusion have occurred following therapeutic doses but usually have cleared spontaneously within several hours.^b ^c

If such symptoms occur, closely observe the patient and check vital signs.^b ^c Caution if pentazocine is reinstated, since acute CNS reactions may recur.^b ^c

AMI

Possible increased systemic and pulmonary arterial pressure and systemic vascular resistance with IV administration in patients with AMI.^c Administer IV with caution in patients with AMI accompanied by hypertension or left ventricular failure.^c

Adminster oral pentazocine with caution in patients with AMI accompanied by nausea and vomiting.^b

Sensitivity Reactions

Sulfite Sensitivity

Some formulations contain sodium metabisulfite or acetone sodium bisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^c

General Precautions

Biliary Tract Surgery

Possible spasm of Oddi’s sphincter; use with caution in patients about to undergo biliary tract surgery.^b ^c

Seizures

Possible occurrence of seizures following administration in seizure-prone patients.^b ^c Use with caution in such patients.^b ^c

Use of Fixed Combinations

When used in fixed combination with acetaminophen, consider the cautions, precautions, and contraindications associated with acetaminophen.^d

Specific Populations

Pregnancy

Category C.^b

Safe use in pregnant women (except during labor) not established.^b ^c Should not be administered to women who are pregnant unless potential benefits outweigh possible risks to fetus.^b ^c Possible abstinence (withdrawal) syndrome in neonates after prolonged maternal use during pregnancy.¹⁰⁰ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵³ ¹⁵⁴

Following parenteral administration during labor, alterations (usually increases) in rate and strength of uterine contractions may occur.^a

Respiratory depression and transient apnea may occur in neonates when administered during labor and delivery;^a use with caution in women delivering premature infants.^b ^c

Lactation

Not known whether pentazocine is distributed into milk; use with caution in nursing women.^b

Pediatric Use

Safety and efficacy of oral pentazocine not established in children <12 years of age.^a ^b

Safety and efficacy of parenteral pentazocine for preoperative sedation not established in infants <1 year of age.^c

Geriatric Use

Possible increased sensitivity to pentazocine in some geriatric individuals.^c

Insufficient experience with pentazocine tablets in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^b

Use with caution due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.^b ^c May be useful to monitor renal function.^c

Select dosage with caution.^b ^c (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution.^b ^c Extensive liver disease may predispose to greater incidence or severity of adverse effects than would be expected from usual doses, probably as a result of decreased hepatic metabolism of the drug.^b ^c

Renal Impairment

Use with caution.^b ^c

Common Adverse Effects

Dizziness, lightheadedness, euphoria, sedation, nausea.^a

Interactions for Pentazocine Hydrochloride

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
CNS depressants (e.g., general anesthetics, phenothiazines or other tranquilizers, anxiolytics, sedatives, hypnotics, alcohol)	Possible additive effects^b ^c	Use with caution to avoid overdosage^b ^c
Fluoxetine	Possible transient symptoms (e.g., diaphoresis, ataxia, flushing, tremor) suggestive of serotonin syndrome^a
Tests for urinary 17-hydroxycorticosteroids	Possible decrease in urinary 17-hydroxycorticosteroid determinations (Porter-Silber reaction)^a	Clinical importance not established^a

Pentazocine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract^b and from IM and sub-Q injection sites.^a

Undergoes first-pass metabolism following oral administration, with <20% of an oral dose reaching systemic circulation as unchanged drug.^a

Onset

Following oral administration, onset of analgesia occurs within 15–30 minutes; peak analgesia occurs within 1–3 hours.^a ^b

Following IM or sub-Q injection, onset of analgesia occurs within 15–20 minutes; peak analgesia occurs within about 1 hour.^a ^c

Following IV administration, onset of analgesia occurs within 2–3 minutes; peak analgesia occurs within 15 minutes.^a ^c

Duration

Following oral administration, duration of analgesia is ≥3 hours.^b

Following IM or sub-Q injection, duration of analgesia is about 2 hours; following IV administration, duration is about 1 hour.^a

Special Populations

In patients with hepatic dysfunction, oral bioavailability may be substantially increased; about 60–70% of an oral dose is reportedly absorbed unchanged in individuals with cirrhosis.¹⁴⁴ ¹⁴⁵

Distribution

Extent

Widely distributed in the body.^a

Crosses the placenta; neonatal serum concentrations reported to average about 65% of maternal concentrations at delivery.^a ^b

Not known whether pentazocine is distributed into milk.^b

Plasma Protein Binding

About 60%.^a

Elimination

Metabolism

Metabolized in the liver.^b

Elimination Route

Excreted prinicipally in urine.^b Less unchanged drug appears to be excreted in urine after oral administration than after IV administration.^a

Half-life

2–3 hours.^b

Special Populations

In patients with hepatic impairment, clearance may be decreased and elimination half-life prolonged.¹⁴⁴ ¹⁴⁵ ¹⁵⁵

In geriatric patients, elimination half-life may be prolonged and systemic exposure to pentazocine increased.^c

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).^b

Parenteral

Injection

15–30°C.^c

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Drug Compatibility

Admixture CompatibilityHID
Incompatible
Aminophylline
Amobarbital sodium
Pentobarbital sodium
Phenobarbital sodium
Sodium bicarbonate

Y-site CompatibilityHID
Compatible
Heparin sodium
Hydrocortisone sodium succinate
Potassium chloride
Vitamin B complex with C
Incompatible
Nafcillin sodium

ActionsActions

Believed to be a competitive antagonist at μ opiate receptors and an agonist at κ and Σ opiate receptors.^a

Analgesic and respiratory depressant activity apparently results mainly from the l-isomer.^a

Produces respiratory depression, sedation, miosis, and antitussive effects.^a

In low doses (15 mg IM), pentazocine inhibits GI motility and slows the rate of gastric emptying; higher doses (30–45 mg) reportedly increase intestinal transit time and produce less elevation of biliary pressure than equianalgesic doses of morphine.^a

Advice to Patients

Potential for pentazocine to impair mental alertness or physical coordination; do not drive or operate machinery until effects on individual are known.^b

Importance of taking exactly as prescribed; do not exceed the recommended dosage.^b

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.^b Importance of avoiding alcohol while receiving the drug.^b

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^b

Importance of advising patients of other important precautionary information.^b ^c (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs. May be subject to more stringent control in some states.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pentazocine and Naloxone Hydrochlorides
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	Pentazocine Hydrochloride 50 mg (of pentazocine) and Naloxone Hydrochloride 0.5 mg (of naloxone)*	Pentazocine and Naloxone Hydrochlorides Tablets ( C-IV)	Amide, Ranbaxy, Watson
			Talwin Nx ( C-IV; scored)	Sanofi-Synthelabo

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pentazocine Hydrochloride Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg (of pentazocine) with Acetaminophen 650 mg*	Pentazocine Hydrochlorides with Acetaminophen Tablets ( C-IV)	Amide, Watson
			Talacen Caplets ( C-IV; with sodium metabisulfite, scored)	Sanofi-Synthelabo

Pentazocine Lactate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	30 mg (of pentazocine) per mL	Talwin ( C-IV; preservative-free in ampuls or with acetone sodium bisulfite and methylparaben in multiple-dose vials)	Hospira

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pentazocine-Naloxone HCl 50-0.5MG Tablets (WATSON LABS): 30/$42.99 or 90/$112.97

Talwin NX 50-0.5MG Tablets (SANOFI-AVENTIS U.S.): 30/$55.99 or 90/$155.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

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a. AHFS Drug Information 2004. McEvoy GK, ed. Pentazocine Hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004.

b. Sanofi-Synthelabous. Talwin Nx (pentazocine and naloxone hydrochlorides) prescribing information. New York, NY; 2003 May.

c. Abbott Laboratories. Talwin (pentazocine lactate) injection prescribing information. North Chicago, IL; 2001 Jan.

d. Sanofi-Synthelabous. Talacen (pentazocine hydrochloride and acetaminophen) prescribing information. New York, NY; 2003 May.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1316-9.

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