Grandaxin - During pregnancy | Use | Dose

This article was medically reviewed by M.Pharm, Marko Tanaskovic on August 12, 2018. To read more about an author, click here.

Grandaxin is a medicine containing the active substance Tofisopam in a dose of 50 mg, and belongs to the family of drugs called benzodiazepines. Although chemically there is very little differences from other benzodiazepines (different position of nitrogen atoms), it manifests quite different pharmacological effects than other benzodiazepines. Unlike other benzodiazepines, it does not exhibit a sedative effect, anticonvulsant effect and muscle-relaxation effect.1

It can be obtained only by prescription, although it is not associated with physical or psychological dependence.

It is used to treat mental disorders associated with increased tension, anxiety, loss of energy, loss of motivation, and depressed mood.

It can also be used to alleviate the symptoms of alcohol withdrawal.

It has no effect on muscle relaxation, and therefore it can be used in patients who have myasthenia gravis.

What precautions to take while on Grandaxin therapy?

Contraindications to the use of this medication include:

  • Hypersensitivity to Tofisopam or other chemically similar drugs
  • Night apnea or breathing cessation during sleep
  • Any difficulty in breathing or any damage to respiratory organs
  • If you have ever been in a coma
  • In patients younger than 18 years

Other conditions that require special precautions during the application of this drug include:

  • Epilepsy
  • Liver disease
  • Glaucoma
  • Kidney disease
  • Obsessive-compulsive disorder
  • Social phobia
  • Depression
  • Personality disorders

Grandaxin during pregnancy

This medication passes the placental barrier and may have a negative impact on the fetus, but there are not enough clinical trials on this topic. It can be applied during pregnancy only in rare cases.

Grandaxin during breastfeeding

It is excreted in breast milk, so you should not breastfeed your baby while you are being treated with this drug.


The usual dose is 50 - 100 mg (one or two tablets) per day, unless your doctor tells you otherwise. In severe conditions, the dose can be increased to 150 mg daily.

Take this medicine regularly, each day at the same time, until your doctor advices you otherwise.

Food does not affect this drug, and it can be taken with a meal.


If taken in doses higher than recommended, Grandaxin may cause the following symptoms:

  • Respiratory depression
  • Coma
  • Epileptic seizures
  • Confusion

Taking other medicines while you are on Grandaxin therapy

Grandaxin can interact with the following medications:

  • Other benzodiazepines (bromazepam, diazepam, lorazepam and others). Co-administration leads to additive (increased) effects on the central nervous system, which increases the risk of depressive activity on the central nervous system
  • Medicines for epilepsy treatment (phenytoin, valproic acid, carbamazepine, phenobarbital, and others)
  • Antidepressants
  • Hypnotics
  • Antiarrhythmics (medicines used to regulate heart rate)
  • Antifungal drugs (ketoconazole, itraconazole, voriconazole, fluconazole, and others)
  • Anticoagulants (medicines for blood clotting disorders)
  • Drugs used to treat heartburn and acid reflux (aluminum hydroxide, calcium carbonate, hydrotalcite, omeprazole, cimetidine, etc.)
  • Oral contraceptive drugs
  • Immunosuppressive agents. Grandaxin exhibits immunomodulatory properties2 and can reduce the efficacy of immunosuppressive agents.
  • Digoxin, digitoxin and izonalid - medicines used to treat cardiac insufficiency

Tell your doctor if you are taking any other medications.

Grandaxin side effects

Side effects of Grandaxin that occur frequently:

  • Gastrointestinal adverse effects (constipation, vomiting, loss of appetite, abdominal pain and flatulence)
  • Adverse effects that are a result of the impact on the central nervous system (insomnia, headache, irritability and psychomotor restlessness)
  • Tension and pain in the muscles
  • Dry mouth
  • A rash similar to scarlatina (scarlet fever)
  • Difficulty breathing

Side effects of Grandaxin that occur rarely:

  • Epileptic seizures in patients already suffering from epilepsy
  • Jaundice due to liver damage
  • Confusion


  1. NCBI link 1
  2. NCBI link 2

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If you have any concerns or questions about your health, you should always consult with a physician or other health-care professional.

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