Diclectin

/ Tzamal

Initially, take two delayed-release tablets orally at bedtime (1^st day). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of 2^nd day, take the usual dose of two tablets at bedtime that night then take three tablets starting on 3^rd day (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on 4^th day, continue taking three tablets daily. Otherwise take 4 tablets starting on 4^th day (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime). The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.  Take on an empty stomach with a glass of water.
Swallow tablets whole. Do not crush, chew, or divide tablets.
Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for drug as her pregnancy progresses.
A gradual tapering dose of the drug is recommended at the time of discontinuation to prevent a sudden onset of symptoms.

Treatment of nausea and vomiting of pregnancy inwomen who do not respond to conservative management.

Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation. Concomitant use with Monoamine oxidase (MAO) inhibitors.           

The 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.
See prescribing information for full details.

The following adverse reactions are discussed elsewhere in the labeling:
Somnolence, Falls or other accidents resulting from the effect of the combined use of DICLECTIN with CNS depressants including alcohol.

Use of this drug is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with this drug is not recommended.
Drug-Food Interactions: A food-effect study demonstrated that the delay in the onset of action of DICLECTIN may be further delayed, and a reduction in absorption may occur when tablets are taken with food .Therefore, the drug should be taken on an empty stomach with a glass of water.

Pregnancy: The drug is intended for use in pregnant women.
Lactation: Women should not breastfeed while using this drug.
See prescribing information for full details. 

Signs and Symptoms of Overdose: This drug 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: Store at 20°C to 25°C excursions permitted between 15°C and 30°C. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle. Protect from light. Once the bottle has been first opened, it should be used within 60 days.
Driving or operating heavy machinery: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using this drug until cleared to do so. Inform women of the importance of not taking this drug with alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could worsen leading to falls or other accidents.