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CLASEPI
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Clasepi (Cannabidiol Oral Solution)

₹9,900.00

Pack Size: 100 mg/ml ( 60ml )

Dosage : As directed by treating Physician / Doctors

or as directed by treating physician/doctor, treating physician/doctor may continue the treatment for longer duration as per the clinical requirement of the individual patient.

Category:
Requires Prescription

Description

Composition: Each ml contains: Cannabidiol Oral solution: 100 mg/ml ( 60ml ) (Non NRX : Non-Narcotic synthetic product)

Instructions for use: Follow your healthcare provider’s instructions for the dose of Cannabidiol to take or give. Ask your healthcare provider  if you are not sure how to prepare, take, or give the prescribed dose of Cannabidiol. Always use the oral syringe provided with Cannabidiol to make sure you measure the right amount of Cannabidiol. Do not use Cannabidiol after the expiration date on the package and each bottle. Use Cannabidiol within 12 weeks of first opening the bottle. After 12 weeks, safely throw away (dispose of) any Cannabidiol that has not been used.

Indications:

  • Seizures Associated with Lennox-Gastaut Syndrome or Dravet Syndrome in patients 1 years of age and older.
  • Seizures Associated with Tuberous Sclerosis Complex in patients 1 year of age and older.

Available Pack Sizes: 100 mg/ml ( 60ml )

Important Safety Information : CBD is possibly safe to take in appropriate doses. With the guidance of a healthcare provider, a specific prescription CBD product may be used at higher doses and for longer durations.

Key Things to Know : CBD reduces seizures and increases seizure control. In particular, CBD used as an add on therapy in Lennox-Gastaut syndrome, Dravet syndrome & Tuberous sclerosis complex patients without seizure control by anti-epileptics results in a greater reduction in seizure frequency

Potential side effects, and any other essential information that should be communicated to customers : Cannabidiol may cause liver problems. Your healthcare provider should do necessary blood tests including LFT (Liver function test) to check your liver function before you start taking Cannabidiol and also during treatment. In some cases, Cannabidiol treatment may need to be stopped. Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment with Cannabidiol

loss of appetite, nausea, vomiting, fever, feeling unwell, unusual tiredness, yellowing of the skin or the eyes (jaundice), itching, unusual darkening of the urine, right upper stomach area pain or discomfort. Cannabidiol may cause you to feel sleepy, which may get better over time. Using certain medicines with Cannabidiol such as clobazam or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until on cannabidiol therapy. Cannabidiol may cause suicidal thoughts or actions in a very small number of people.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying
  • Attempt to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood
Important safety information while taking CLASEPI

What is the Most Important Information I Should Know About CLASEPI (cannabidiol)?

Do not take if you are allergic to cannabidiol or any of the ingredients in CLASEPI (cannabidiol).

CLASEPI (cannabidiol) may cause liver problems. Your doctor may order blood tests to check your liver before you start taking CLASEPI (cannabidiol) and during treatment. In some cases, CLASEPI (cannabidiol) treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with CLASEPI (cannabidiol):

  • loss of appetite, nausea, vomiting
  • fever, feeling unwell, unusual tiredness
  • yellowing of the skin or the whites of the eyes (jaundice)
  • itching
  • unusual darkening of the urine
  • right upper stomach area pain or discomfort

Side effects-

1. Hepatocellular Injury

Cannabidiol can cause dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]).

2. Somnolence and Sedation

Cannabidiol can cause somnolence and sedation. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on Cannabidiol to gauge whether it adversely affects their ability to drive or operate machinery.

3. Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Cannabidiol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behaviour.

4. Hypersensitivity Reactions

Cannabidiol can cause hypersensitivity reactions. Cannabidiol is contraindicated in patients with a prior hypersensitivity reaction to cannabidiol or any of the ingredients in the product, which includes sesame seed oil.

5. Withdrawal of Antiepileptic Drugs (AEDs)

As with most antiepileptic drugs, Cannabidiol should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

Precautions

  • Can cause hepatic transaminase elevations
  • Monitor for Somnolence and sedation.
  • Monitor patients for suicidal behavior and thoughts
  • Hypersensitivity Reactions
  • For Withdrawal of Antiepileptic Drugs Cannabidiol should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
 

Effects on ability to drive and use machines:

Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation. Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities.

Use in Specific Population:

  • Paediatrics: Safety and effectiveness of cannabdiol in children aged below 1 year have not been established.
  • Pregnancy: There are no adequate data on the developmental risks associated with the use of cannabidiol in pregnant women.
  • Breast-feeding: There are no data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • Hepatic Impairment: Because of an increase in exposure to cannabididol, dosage adjustments are necessary in patients with moderate or severe hepatic impairment.
  • Renal impairment: Cannabidiol can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment. There is no experience in patients with end-stage renal disease. It is not known if cannabidiol is dialysable.

Contraindication:

Cannabidiol is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the ingredients in the product.

 

Overdose

Symptoms

Experience with doses higher than the recommended therapeutic dose is limited. Mild to moderate diarrhoea and somnolence have been reported in healthy adult subjects taking a single dose of 6000 mg; this equates to a dose of over 85 mg/kg for a 70 kg adult. These adverse reactions resolved upon study completion.

Management of overdose

In the event of overdose, the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs