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Firstly, phentermine 37.5 mg tablet is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.
ADIPEX-P® , an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).
Also, ADIPEX-P® Capsules contain the inactive ingredients Black Iron Oxide, Corn Starch, D&C Red #33, FD&C Blue #1, Gelatin, Lactose Monohydrate, Magnesium Stearate, Propylene Glycol, Shellac, and Titanium Dioxide.
Furthermore, ADIPEX-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.
INDICATIONS
Because, ADIPEX-P® is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
DOSAGE AND ADMINISTRATION
Exogenous Obesity
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.
ADIPEX-P® is not for use in pediatric patients less than or equal to 16 years of age.
Avoid late evening medication should be because of the possibility of resulting insomnia.
Dosage In Patients With Renal Impairment
The recommended maximum dosage of ADIPEX-P® is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2 ). Avoid use of ADIPEX-P® in patients with eGFR less than 15 mL/min/1.73 m2 or end-stage renal disease requiring dialysis [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
HOW SUPPLIED
Dosage Forms And Strengths
Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).
Storage And Handling
Firstly, Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Also, Each blue and white, oblong, speckled, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Furthermore, Each capsule is with “ADIPEX-P” – “37.5” on the cap and two stripes on the body using dark blue ink.
Tablets are in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).
Capsules are in bottles of 100 (NDC 57844-019-01).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
SIDE EFFECTS
Firstly, we can describe the following adverse reactions, or described in greater detail, in other sections:
- Primary pulmonary hypertension [see WARNINGS AND PRECAUTIONS]
- Also, Valvular heart disease [see WARNINGS AND PRECAUTIONS]
- Effect on the ability to engage in potentially hazardous tasks [see WARNINGS AND PRECAUTIONS]
- Withdrawal effects following prolonged high dosage administration [see Drug Abuse And Dependence]
The following adverse reactions to phentermine have been identified:
Cardiovascular
Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.
Central Nervous System
Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.
Gastrointestinal
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
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