Composition: Each delayed release tablet contains :

Doxylamine succinate 10 mg

Pyridoxine Hcl (Vitamin B6) 10 mg

Excipients: Lactose, microcrystalline cellulose, eudragit, aerosil, PVP K30

Pharmacokinetics:

Absorption: Doxylamine and pyridoxine are absorbed in the gastrointestinal tract, mainly in the jejunum. The C_max of doxylamine and pyridoxine are achieved within 7.5 and 5.5 hours, respectively.

Food effect: The administration of food delays the absorption of both doxylamine and pyridoxine. This delay is associated with a lower peak concentration of doxylamine, but the extent of absorption is not affected.

Distribution: Pyridoxine is highly protein bound, primarily to albumin.

Metabolism: Doxylamine is biotransformed in the liver to its principle metabolites.

Pyridoxine is a prodrug primarily metabolized in the liver.

Excretion: The principle metabolites of doxylamine are excreted by the kidney. The terminal elimination half-life of doxylamine and pyridoxine are 12.5 hours and 0.5 hours, respectively.

Indications:

VITACLOZINE is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitations of Use: This drug has not been studied in women with hyperemesis gravidarum.

Contraindications:

• Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation.
• Monoamine oxidase inhibitors intensify and prolong the adverse central nervous system effects of VITACLOZINE.

Warnings & Precautions:

Activities Requiring Mental Alertness: This drug may cause somnolence. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using VITACLOZINE.

The use of VITACLOZINE is not recommended if a woman is concurrently using central nervous system depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents.

Concomitant Medical Conditions: THIS DRUG has anticholinergic properties and, therefore, should be used with caution in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.

Pregnancy:

Category A, VITACLOZINE is intended for use in pregnant women.

Lactation:

Women should not breastfeed while using THIS DRUG.

Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of THIS DRUG resulting in worsening of their apnea or respiratory conditions.

Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.

Pediatric Use

The safety and effectiveness of THIS DRUG in children under 18 years of age have not been established.

Drug Interactions

• Use of VITACLOZINE is contraindicated in women who are taking monoamine oxidase inhibitors, which prolong and intensify the anticholinergic (drying) effects of antihistamines.
• Concurrent use of alcohol and other CNS depressants (such as hypnotic, sedatives) with VITACLOZINE is not recommended.

Side effect:

Somnolence, Falls or other accidents resulting from the effect of the combined use of  VITACLOZINE with CNS depressants including alcohol.

Postmarketing Experience:

dyspnea, palpitation, tachycardia, vertigo, blurred vision, visual disturbances, abdominal distension, abdominal pain, constipation, diarrhea, chest discomfort, fatigue, irritability, malaise, hypersensitivity, dizziness, headache, migraines, paresthesia, psychomotor hyperactivity, anxiety, disorientation, insomnia, nightmares, dysuria, urinary retention, hyperhidrosis, pruritus, rash, maculo-papular rash.

Doses & Administration:

• Initially, take two delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).
• The maximum recommended dose is four tablets daily.
• the delay in the onset of action of this drug may be further delayed, and a reduction in absorption may occur when tablets are taken with food. Therefore, it should be taken on an empty stomach with a glass of water.
• Swallow tablets whole. Do not crush, or chew the tablets.
• Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for THIS DRUG as her pregnancy progresses.

Overdoses:

VITACLOZINE is a delayed-release formulation, therefore, signs and symptoms of intoxication may not be apparent immediately.

Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia. At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.

If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment.

Storage conditions: Store in a cool and dry place below 25°c.

How supplied: A carton box contains 20 delayed release tablets of  VITACLOZINE.