Vertical Pharmaceuticals Inc.
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Vertical Pharmaceuticals Inc. Drugs
SHAKE WELL BEFORE USING. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 to 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
DOSAGE AND ADMINISTRATION1
Adults and Children 12 years of age and older: 1-2 teaspoonfuls every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period.
Children 6 to 12 years of age: 1/2 to 1 teaspoonful every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.1 In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
Apply ZyPram™ cream to the affected area(s) three times daily or as directed by a physician. ZyPram™ should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of ZyPram™, or should worsen, discontinue use and seek the advice of your physician. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted
2.1 General Dosing Considerations
ConZip™ is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].
Do not administer ConZip™ at a dose exceeding 300 mg per day. Do not use ConZip™ more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release Products
Initiate treatment with ConZip™ at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability.
2.3 Patients Currently on Tramadol Immediate-Release Products
Calculate the 24-hour tramadol IR dose and initiate a total daily dose of ConZip™ rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with ConZip™, some patients maintained on tramadol IR products may not be able to convert to ConZip™.
2.4 Patients 65 Years of Age and Older
Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, 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. ConZip™ should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
2.5 Patients with Renal Impairment
The limited availability of dose strengths and once daily dosing of ConZip™ do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use ConZip™ in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic Impairment
The limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use ConZip™ in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of Treatment
Withdrawal symptoms may occur if ConZip™ is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering ConZip™ [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food Effects
ConZip™ may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
Adults and Children over 10 years of age: Usual dose is one 150 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. ZonatussTM capsules should be swallowed whole. ZonatussTM capsules are not to be broken, chewed, dissolved, cut or crushed.
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