Debritone (20mg) 60ml Elixir

Debritone (20mg) 60ml Elixir

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  • Manufacturer XENON PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Phenobarbitone

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Phenobarbitone Elixir, a barbiturate, exerts its therapeutic effects primarily by enhancing the inhibitory action of gamma-aminobutyric acid (GABA) in the central nervous system. GABA is a neurotransmitter that inhibits neuronal activity, and phenobarbitone facilitates its effect by increasing the duration of chloride ion channel opening, leading to hyperpolarization of neurons and reduced neuronal excitability. This mechanism results in sedative, anticonvulsant, and anxiolytic effects. The drug binds to specific barbiturate binding sites on the GABA receptor complex, prolonging the time that GABA receptors remain open, thereby increasing the influx of chloride ions and stabilizing neuronal membranes in the brain. This prolonged activation of GABA receptors is responsible for the central nervous system depression and therapeutic actions observed with Phenobarbitone Elixir.

  • Ingredients

    Phenobarbitone
  • Drug Class

    Barbiturate

  • Dosage Form

    Elixir

  • Uses

    The following are the uses of Phenobarbitone Elixir:

    • Used for controlling seizures and treating epilepsy in both children and adults.
    • Used for managing anxiety and promoting relaxation in patients with severe anxiety disorders.
    • Used for treating insomnia and improving sleep patterns in individuals with chronic sleep disorders.
    • Used for providing pre-operative sedation to reduce anxiety and calm patients before surgery.
    • Used for managing withdrawal symptoms during alcohol detoxification, making the process safer and more comfortable.
    • Used for relieving pain and reducing muscle spasms in certain neurological conditions.
    • Used for managing neonatal seizures in infants, ensuring their safety and brain health.
  • In case of Overdose

    In the case of an overdose of Phenobarbitone Elixir, the severity of symptoms can vary based on the amount ingested. Common signs include increased drowsiness, confusion, and impaired coordination. In more severe cases, individuals may experience difficulty breathing, a rapid or weak pulse, and even loss of consciousness. Prompt medical intervention is necessary to manage these symptoms and ensure the patient's safety, as delayed treatment can lead to serious complications.

  • Missed Dose

    In the case of a missed dose of Phenobarbitone Elixir, it is generally advised to administer the medication as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. It is important not to double the dose to make up for a missed one, as this can lead to an overdose. If you frequently miss doses, inform your healthcare provider, as they may need to adjust the dosage or provide further guidance on managing missed doses. Always keep a consistent dosing routine to ensure the medication's effectiveness.

  • How To Use

    To administer Phenobarbitone Elixir, shake the bottle thoroughly, then measure the prescribed dose with an accurate measuring device like a marked syringe, and administer it orally, following the dosage instructions provided by your healthcare professional, typically once or twice daily as directed.

  • When Not to Use

    Here are the conditions and situations when Phenobarbitone Elixir should not be used:

    • Allergy or hypersensitivity to Phenobarbitone or barbiturates.
    • Patients with a known history of porphyria (a disorder affecting the skin and nervous system).
    • Contraindicated in patients with severe respiratory conditions or severe asthma.
    • Should not be used in patients with acute intermittent porphyria.
    • Not suitable for individuals with severe liver impairment or cirrhosis.
    • Avoid use in patients with a history of severe kidney disease.
    • Contraindicated during pregnancy, especially during the first and last trimesters.
    • Not recommended for breastfeeding mothers as it can pass into breast milk.
    • Do not use in patients with a history of severe respiratory depression or hypercapnia.
    • Should be avoided in patients with a known history of severe anemia.
  • Side Effects

    The side effects of Phenobarbitone Elixir may include:

    • Drowsiness or sedation
    • Dizziness
    • Ataxia (loss of balance or coordination)
    • Confusion or cognitive impairment
    • Skin rashes or itching
    • Allergic reactions (hives, swelling, difficulty breathing)
    • Gastrointestinal issues (nausea, vomiting, diarrhea)
    • Behavioral changes (agitation, irritability)
  • Precautions & Warnings

    Following are the precautions and warnings for Phenobarbitone Elixir:

    • Avoid in patients with a known hypersensitivity or allergy to barbiturates.
    • Use with caution in individuals with a history of liver or kidney disease, as dosage adjustments may be necessary.
    • May cause drowsiness and impair your ability to drive or operate machinery; avoid such activities until you know how the medication affects you.
    • Alcohol consumption should be avoided as it can increase the sedative effects of Phenobarbitone.
    • Not recommended for use in children unless under medical supervision.
    • Pregnant and breastfeeding women should consult their doctor, as Phenobarbitone may have potential risks for the fetus and infant.
    • Long-term use may lead to physical dependence; follow your doctor's instructions for dosage and duration.
  • Drug Interactions

    Following are the drug interactions for Phenobarbitone Elixir:

    • Alcohol and other central nervous system (CNS) depressants like benzodiazepines can increase the sedative effects, leading to excessive drowsiness and impaired breathing.
    • It may decrease the effectiveness of hormonal birth control methods like pills, patches, or rings, potentially leading to unplanned pregnancy.
    • Phenobarbitone can induce certain liver enzymes, affecting the metabolism of other drugs such as warfarin, phenytoin, and certain antidepressants, potentially requiring dose adjustments.
    • Combining with other barbiturates or sedative-hypnotics can result in additive CNS depression and respiratory suppression.
    • The effectiveness of Phenobarbitone may be reduced when used with enzyme inducers such as rifampicin or St. John's Wort.
    • It may decrease the plasma levels of doxycycline, potentially reducing its antibacterial efficacy.
    • Phenobarbitone can increase the metabolism of corticosteroids, requiring close monitoring and potential dose adjustments.
  • Food Interactions

    Following are the food interactions for Phenobarbitone Elixir:

    • Grapefruit juice should be avoided as it can increase the effects of Phenobarbitone by altering its metabolism, potentially leading to increased sedation and prolonged effects.
    • Alcohol consumption is not recommended as it can enhance the sedative properties of Phenobarbitone, causing excessive drowsiness and impaired coordination.
    • High-fat meals may slow down the absorption of Phenobarbitone, delaying its onset of action.
    • Caffeine-rich foods and beverages might counteract the sedative effects of Phenobarbitone, making it less effective for sleep disorders.
    • Avoid herbal supplements like St. John's Wort, as they can affect the metabolism of Phenobarbitone, altering its effectiveness.
    • Dairy products might interfere with the absorption of Phenobarbitone, especially when taken together.
    • Consuming large amounts of chocolate, which contains theobromine, can potentially interact with Phenobarbitone, affecting its metabolism.
    • Always consult a healthcare professional for specific dietary advice while taking Phenobarbitone, as individual responses to food interactions may vary.
  • Storage/Disposal

    Phenobarbitone Elixir should be stored in a secure and controlled environment, preferably in a locked cabinet or a designated medication storage area, maintaining a consistent room temperature between 68°F to 77°F (20°C to 25°C). Protect the elixir from direct sunlight, heat, and moisture, ensuring it remains in its original container with the cap tightly sealed to prevent contamination. Regularly check the expiration date, and dispose of any outdated or unused medication properly. When disposing of Phenobarbitone Elixir, do not pour it down the sink or toilet; instead, follow local guidelines or consult a pharmacist for safe disposal methods to protect the environment and prevent unauthorized access. Keep the medication out of children's reach to avoid accidental ingestion, ensuring their safety.

  • Quick Tips, if any

    Following are the quick tips for Phenobarbitone Elixir:

    • Always administer the elixir as directed by your doctor or pharmacist.
    • Measure the dose accurately using the provided measuring cup or oral syringe.
    • Administer the elixir orally, and ensure the child swallows it completely.
    • Avoid mixing the elixir with other liquids or medications unless instructed.
    • Store the elixir at room temperature, away from direct sunlight and moisture.
    • Do not use the medication if it has expired or shows signs of discoloration.
    • Contact your healthcare provider if you notice any unusual symptoms or side effects.

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