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Tigan Indications, Dosage, Storage, Stability - Trimethobenzamide hydrochloride

Tigan Indications, Dosage, Storage, Stability - Trimethobenzamide hydrochloride

INDICATIONS

Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

DOSAGE AND ADMINISTRATION

(See WARNINGS and PRECAUTIONS.)

Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

CAPSULES, 300 mg

Usual Adult Dosage

One 300 mg capsule t.i.d. or q.i.d.

SUPPOSITORIES, 200 mg (not to be used in premature or newborn infants)

Usual Adult Dosage

One suppository (200 mg) t.i.d. or q.i.d.

Usual Children's Dosage

Under 30 lbs: One-half suppository (100 mg) t.i.d. or q.i.d.

30 to 90 lbs: One-half to one suppository (100 to 200 mg) t.i.d. or q.i.d.

SUPPOSITORIES, PEDIATRIC, 100 mg (not to be used in premature or newborn infants)

Usual Children's Dosage

Under 30 lbs: One suppository (100 mg) t.i.d. or q.i.d.

30 to 90 lbs: One to two suppositories (100 to 200 mg) t.i.d. or q.i.d.

INJECTABLE, 100 mg/mL (not for use in children)

Usual Adult Dosage

2 mL (200 mg) t.i.d. or q.i.d. intramuscularly.

NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use. Intramuscular administration may cause pain, stinging, burning, redness and swelling at the site of injection. Such effects may be minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.

STORAGE

Store at 25°C (77°F).

Excursions permitted to 15–30°C (59–86°F).

HOW SUPPLIED

Capsules, 300 mg trimethobenzamide hydrochloride each, bottles of 100 and 500 NDC 61570-079-01 300 mg 100’s NDC 61570-079-05 300 mg 500’s Suppositories, Pediatric, 100 mg, boxes of 10 Suppositories, 200 mg, boxes of 10 and 50 NDC 61570-503-10 100 mg (box of 10) NDC 61570-504-10 200 mg (box of 10) NDC 61570-504-50 200 mg (box of 50) Ampuls, 2 mL, boxes of 10 NDC 61570-540-02 100 mg/mL in 2 mL ampul Multi-Dose Vials, 20 mL

NDC 61570-541-20 100 mg/mL in 20 mL Multi-Dose Vials

Distributed By: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured By: King Pharmaceuticals, Inc., Bristol, TN 37620

Rev. 5/01,0934128

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