chlorpheniramine maleate, methscopolamine nitrate
Dosage Form: tablets
RespiVent Dosepack DF
RespiVent Dosepack DF Description
Each AM tablet contains:
Chlorpheniramine Maleate. ….4 mg
Methscopolamine Nitrate…..2.5 mg
Each PM tablet contains:
Chlorpheniramine Maleate. ….8 mg
Methscopolamine Nitrate…..2.5 mg
Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1).
Chlorpheniramine maleate
Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-,nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 80.4
Methscopolamine nitrate
Inactive Ingredients:
AM tablets: Each white AM tablet contains Hypromellose, Dicalcium Phosphate, Talc, Stearic Acid and Magnesium Stearate.
PM tablets: Each blue PM tablet contains Hypromellose, Dicalcium Phosphate, Talc, FD&C Blue #1 (aluminum lake) Dye, Stearic Acid and Magnesium Stearate.
CLINICAL PHARMACOLOGY
Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.
Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain
barrier. Its antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably absorbed. Drug effects appear in about one hour and
persist for about 4 to 6 hours. It is excreted primarily in the urine and bile, or as unabsorbed drug in feces.
INDICATIONS AND USAGE
For the temporary relief of symptoms associated with allergic rhinitis.
CONTRAINDICATIONS
This product is contraindicated in patients with hypersensitivity to methscopolamine nitrate and chlorpheniramine maleate. RespiVent™ DF is contraindicated in patients with severe hypertension, severe coronary artery disease, and in nursing mothers.
RespiVent™ DF is also contraindicated in patients with narrow-angle glaucoma, and peptic ulcer.
WARNINGS
Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage. Methscopolamine nitrate may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or performing hazardous work while taking RespiVent™ DF.
Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of RespiVent™ DF and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and RespiVent™ DF together is not recommended.
Precautions
General
RespiVent™ DF should be used with caution in patients with diabetes mellitus, hypertension, and cardiovascular disease. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.
Drug Interactions
Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.
Pregnancy Category C
It is not known whether RespiVent™ DF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RespiVent™ DF should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether this combination drug is excreted in human milk.
Pediatric Use
The safety and effectiveness in children under 12 years of age have not been established.
Geriatric Use
The elderly (60 years and older) are more likely to experience adverse reactions to methscopolamine.
ADVERSE REACTIONS
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, and increased irritability or excitement (especially in children). Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision, and excessive dryness of the nose, throat, and mouth.
OVERDOSAGE AND TREATMENT OF OVERDOSAGE
The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Since the effects of RespiVent™ DF last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.
DOSAGE AND ADMINISTRATION
Adults and adolescents 12 years of age and over: One white AM tablet in the morning and one blue PM tablet in the evening. RespiVent™ DF is not recommended for children under 12 years of age.
HOW SUPPLIED
(NDC 24486-704-20) RespiVent™ DF Tablets 10 Day Treatment Regimen, containing 20 tablets as follows:
10 white elongated and scored AM tablets debossed with “CBP” on one side and "03" to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
10 blue, elongated and scored PM tablets debossed with “CBP” on one side and "02" to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
(NDC 24486-704-60) RespiVent™ DF Tablets 30 Day Treatment Regimen, containing 60 tablets as follows:
30 white elongated and scored AM tablets debossed with “CBP” on one side and "03" to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
30 blue, elongated and scored PM tablets debossed with “CBP” on one side and "02" to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
Keep out of reach of pediatric population.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature.
Distributed by Aristos Pharmaceuticals, LLC., Cary, NC 27518.
Patent Pending
Aristos Pharmaceuticals
ARR202A0108
RespiVent Dose Pack DF
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 07/01/2008 | ||
| Labeler - Aristos Phamaceuticals Incorporated (153886994) |
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