Doxylamine 15 mg – [30 tablets]

Description

Doxylamine Pharmacodynamics
H1-histamine receptor blocker from ethanolamine group. The drug has a hypnotic, sedative and m-cholinoblocking effect. It shortens the time of falling asleep, increases the duration and quality of sleep, and does not change the phase of sleep. Duration of action is 6-8 hours.

Indications
Transient sleep disorders.

Contraindications .
– Hypersensitivity to doxylamine and other components of the drug, or to other antihistamines;
– Closed angle glaucoma or a family history of closed angle glaucoma;
– Diseases of the urethra and prostate accompanied by urinary outflow disorders;
– Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
– Childhood and adolescence (under 15 years).
Caution
Patients with a history of apnea – due to the fact that doxylamine succinate may aggravate nocturnal apnea syndrome (sudden respiratory arrest in sleep).
Patients over 65 years of age – due to possible dizziness and delayed reactions with the risk of falls (e.g., when waking up at night after taking sleeping pills), as well as due to possible prolongation of Tsh.
Patients with renal and hepatic impairment (Tsh may be prolonged).
Administration during pregnancy and breastfeeding
Based on adequate and well-controlled studies, doxylamine can be used in pregnant women throughout pregnancy.
If this drug is prescribed in late pregnancy, the atropine-like and sedative properties of doxylamine should be taken into account when monitoring the condition of the newborn.
It is unknown whether doxylamine penetrates into breast milk. Due to the possibility of development of sedative or excitatory effects in the baby, breastfeeding should not be done when using the drug.

Dosage and administration

• Inside. Take 1/2 to 1 tablet daily with some fluids 15 to 30 minutes before sleep.
  If the treatment is ineffective, the dose can be increased to two tablets, according to a doctor’s recommendation.
• The duration of treatment is two to five days. If insomnia persists, consult a physician.
• Use in special groups of patients
• Patients with renal and hepatic insufficiency
  Due to the data on increase of plasma concentration and decrease of plasma clearance of doxylamine it is recommended to correct the dose downward.
• Patients over 65 years of age.
• H1-histamine receptor blockers should be used with caution in this group of patients because of possible dizziness and delayed reactions with the risk of falling (e.g., in nighttime awakenings after taking sleeping pills). Due to the data on increased plasma concentrations, decreased plasma clearance and prolonged T1/2, a downward adjustment of the dose is recommended.