Indicated for Hypersensitivity reactions,Insomnia
First generation (sedating) Antihistamines
Doxylamine Succinate is an antihistamine that blocks Histamine (H1) receptor. It can cross the blood brain barrier and has a high affinity for H1 receptors in the brain that blocks H1 receptors. It also decreases the action of histamine at the H1 receptor by inhibiting both vestibular system & Muscarinic receptor. It affects the vestibular system & decreases the stimulation of the vomiting center. Its muscarinic receptor inhibition may also play a role in antihistamine antiemetic activity. Pyridoxine Hydrochloride is a vitamin B6 analog. It is used to prevent nausea and vomiting due to its antiemetic properties.
Hypersensitivity reactionn: 25 mg every 4-6 hr. Max: 150 mg daily. Insomnia: 25 mg given 30 minutes before retiring at night. Should be taken with food. Take with food or milk.
Use of Doxylamine Succinate & Pyridoxine Hydrochloride is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers) with Doxylamine Succinate & Pyridoxine Hydrochloride is not recommended.
Contraindications Severe liver disease; avoid alcohol; premature infants or full-term neonates.
Slight drowsiness to deep sleep,lassitude,dizziness,incoordination. Headache,psychomotor impairment and antimuscarinic effects. Rarely rashes and hypersensitivity reactions,blood disorders,convulsions,sweating,myalgia,extrapyramidal effects,tremor,confusion,tinnitus,hypotension,hair loss.
Category A: Controlled studies in women fail to demonstrate a risk to the fetus in the 1st trimester (and there is no evidence of a risk in later trimesters),and the possibility of fetal harm remains remote.
Doxylamine Succinate & Pyridoxine Hydrochloride is an extended-release or 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 Succinate 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.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.
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