Tigan 300 MG Oral Capsule
WARNINGS
Caution should be exercised when administering Tigan to children for the treatment of vomiting.
Antiemetics are not recommended for treatment of uncomplicated vomiting in children and their use should be limited to prolonged vomiting of known etiology.
There are two principal reasons for caution: 1.
The extrapyramidal symptoms which can occur secondary to Tigan may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye’s syndrome or other encephalopathy.
2.
It has been suspected that drugs with hepatotoxic potential, such as Tigan , may unfavorably alter the course of Reye’s syndrome.
Such drugs should therefore be avoided in children whose signs and symptoms (vomiting) could represent Reye’s syndrome.
Tigan may produce drowsiness.
Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined.
Usage in Pregnancy: Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested.
The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg.
In each study these adverse effects were attributed to one or two dams.
The relevance to humans is not known.
Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.
Usage with Alcohol: Concomitant use of alcohol with Tigan may result in an adverse drug interaction.
DESCRIPTION
Chemically, trimethobenzamide HCl is N-[ p -[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride.
It has a molecular weight of 424.93 and the following structural formula: Capsules: Each 300-mg Tigan capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg.
The capsule has an opaque purple cap marked “Tigan” and an opaque purple body marked “M079”.
Inactive Ingredients: D&C Red No.
28, FD&C Blue No.
1, lactose, magnesium stearate, starch and titanium dioxide.
MM1
HOW SUPPLIED
Capsules, 300 mg trimethobenzamide hydrochloride each, bottles of 100 NDC 61570-079-01 300 mg 100’s RX ONLY Prescribing Information as of April 2008.
Distributed By: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured By: King Pharmaceuticals, Inc., Bristol, TN 37620
INDICATIONS AND USAGE
INDICATIONS & USAGE Tigan is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION (See WARNINGS and PRECAUTIONS .) Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.
Geriatric Patients Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m 2 ).
Final dose adjustment should be based upon integration of clinical efficacy and safety considerations.
(See CLINICAL PHARMACOLOGY and PRECAUTIONS ).
Patients with Renal Impairment In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m 2 ), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered.
(See CLINICAL PHARMACOLOGY and PRECAUTIONS ).
CAPSULES, 300 mg Usual Adult Dosage One 300 mg capsule t.i.d.
or q.i.d.