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IONAMIN (PHENTERMINE RESIN COMPLEX): PRESCRIBING INFORMATION

DESCRIPTION

Ionamin 15 and Ionamin 30 contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is Alpha,Alpha-Dimethyl Phenethylamine (phenyl-tertiarybutylamine).

Inactive ingredients: calcium phosphate dibasic, iron oxides (15 mg capsules only), gelatin, magnesium stearate, lactose, titanium dioxide, FD&C Yellow No. 6, D&C Yellow No. 10.


CLINICAL PHARMACOLOGY

Ionamin clinical pharmacology


INDICATIONS AND USAGE

Ionamin (Phentermine Resin Complex) capsules are 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 >= 30 kg/m2, or >= 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

The limited usefulness of Ionamin and other agents of this class should be measured against possible risk factors inherent in their use such as those described below.


CONTRAINDICATIONS

Advanced arteriosclerosis, moderate to severe hypertension, cardiovascular disease, hyperthyroidism, glaucoma, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines.

Patients with a history of drug abuse.

Agitated states.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).


WARNINGS

Ionamin warnings


PRECAUTIONS

Caution is to be exercised in prescribing Ionamin (Phentermine Resin) for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine Resin (Ionamin) and the concomitant dietary regimen.

Ionamin (Phentermine Resin) capsules may decrease the hypotensive effect of adrenergic neuron blocking drugs.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.


ADVERSE REACTIONS

Ionamin adverse reactions


DOSAGE AND ADMINISTRATION

One capsule daily, before breakfast or 10-14 hours before retiring.

For individuals exhibiting greater drug responsiveness, Ionamin 15 will usually suffice. Ionamin 30 is recommended for less responsive patients. Phentermine Resin is not recommended for use in pediatric patients under 16 years of age.

Ionamin (Phentermine Resin Complex) capsules should be swallowed whole.


OVERDOSAGE

Ionamin overdosage


HOW SUPPLIED

Ionamin (Phentermine Resin) capsules are available in two strengths:

  • 15 mg, yellow / grey capsules, imprinted with "IONAMIN 15", NDC 100 and 400.
  • 30 mg, yellow / yellow capsules, imprinted with "IONAMIN 30", NDC 100 and 400.

    Dispense in a tight container. Store at room temperature. Keep out of the reach of children.

    Manufactured and distributed by: Celltech Pharmaceuticals, Inc.

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