PANGRAF 1.0 Capsules (Hard Gelatin)

What is PANGRAF 1.0

PANGRAF 1.0 is a prescription medicine that contains Tacrolimus, an immunosuppressant used primarily to prevent organ rejection in patients who have undergone kidney, liver, or heart transplantation. It belongs to a class of drugs known as calcineurin inhibitors, which suppress the activity of the immune system to help prevent the body from attacking the transplanted organ.

• Form: Hard gelatin capsules
• Strength: 1.0 mg Tacrolimus per capsule
• Packaging: 60's (10 capsules per blister strip × 6 strips)
• Therapeutic Class: Immunosuppressive agent

Tacrolimus is often used in combination with other immunosuppressants, such as corticosteroids or mycophenolate mofetil. The goal is to achieve the right balance of immune suppression to prevent rejection without increasing the risk of serious infections or malignancies.

PANGRAF 1.0 is typically prescribed and monitored by a transplant specialist or physician experienced in immunosuppressive therapy, due to the complexity and potential risks associated with its use.

How to use PANGRAF 1.0

It is crucial to take PANGRAF 1.0 exactly as directed by your healthcare provider to ensure effective immunosuppression and to avoid potential complications. This medication requires close monitoring and strict adherence.

• Administration: Take the capsules orally, usually twice daily (every 12 hours), on an empty stomach or consistently with or without food to maintain stable blood levels.
• Swallow Whole: Do not open, crush, or chew the capsules. Swallow them whole with a full glass of water.
• Timing: Take doses at the same times each day to maintain consistent blood levels of the drug.
• Avoid Grapefruit: Do not consume grapefruit or grapefruit juice as it can interfere with drug metabolism and increase toxicity.
• Missed Dose: If a dose is missed and it’s close to your next dose, skip the missed dose. Do not double up to make up for it.
• Monitoring: Regular blood tests are required to monitor drug levels and kidney function.

Always carry your medication with you when traveling and keep a consistent dosing schedule. Inform any healthcare provider you visit that you are taking tacrolimus, especially before any surgical procedure or starting new medications.

Mode of Action PANGRAF 1.0

PANGRAF 1.0 (Tacrolimus) exerts its immunosuppressive effects by targeting T-cell activation, a key event in the immune response that leads to organ rejection.

• Calcineurin Inhibition: Tacrolimus binds to an intracellular protein called FK506-binding protein (FKBP-12). This complex inhibits an enzyme called calcineurin.
• T-cell Suppression: By inhibiting calcineurin, tacrolimus prevents the activation of T-lymphocytes, which are white blood cells involved in immune response and organ rejection.
• Cytokine Reduction: It also suppresses the production of interleukin-2 (IL-2) and other cytokines, which are necessary for the proliferation and activity of T-cells.
• Selective Action: The drug’s action is relatively selective to immune cells, helping reduce the risk of generalized immunosuppression seen with other agents.

This mechanism makes PANGRAF effective in preventing acute and chronic transplant rejection. However, due to its potency and narrow therapeutic window, it requires careful dose titration and routine monitoring of blood levels.

PANGRAF 1.0 Interactions PANGRAF 1.0

Tacrolimus has a high potential for drug interactions due to its metabolism via the cytochrome P450 3A enzyme system in the liver and intestines. Combining PANGRAF 1.0 with certain medications can either increase the risk of toxicity or reduce its effectiveness.

• Drugs that Increase Tacrolimus Levels:
  • Azole antifungals (e.g., ketoconazole, fluconazole)
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin)
  • Calcium channel blockers (e.g., diltiazem, verapamil)
  • HIV protease inhibitors
• Drugs that Decrease Tacrolimus Levels:
  • Rifampicin
  • Phenytoin
  • Carbamazepine
  • St. John’s Wort (herbal)
• Other Risky Combinations:
  • NSAIDs and aminoglycosides (increased risk of nephrotoxicity)
  • Live vaccines (risk of reduced efficacy or infection)
  • Cyclosporine (additive nephrotoxicity)

Patients should always inform their healthcare provider about all prescription, non-prescription, and herbal products they are taking to avoid potentially harmful interactions.

Dosage of PANGRAF 1.0

The dosage of PANGRAF 1.0 is individualized based on patient-specific factors including body weight, organ type, time post-transplant, and response to therapy. Blood concentrations of tacrolimus must be closely monitored.

• Initial Dose (Adults):
  • Kidney transplant: 0.15–0.20 mg/kg/day in two divided doses
  • Liver transplant: 0.10–0.15 mg/kg/day in two divided doses
  • Heart transplant: 0.075 mg/kg/day in two divided doses
• Maintenance Dose:
  • Adjusted to maintain target blood trough levels (usually 5–15 ng/mL)
  • Dose titration based on trough level, organ function, and signs of rejection or toxicity
• Special Populations:
  • Hepatic impairment: May require dose reduction
  • Renal impairment: Use with caution and monitor closely

Dosing must be managed by specialists, with frequent blood tests to adjust the dose and prevent complications such as rejection or tacrolimus toxicity.

Possible side effects of PANGRAF 1.0

PANGRAF 1.0 may cause side effects that range from mild to severe. Most adverse effects are dose-related and may be reduced by dose adjustment.

• Common Side Effects:
  • Tremors
  • Headache
  • Insomnia
  • Nausea, diarrhea
  • High blood pressure
  • Increased blood sugar (may cause or worsen diabetes)
• Serious Side Effects:
  • Nephrotoxicity (kidney damage)
  • Neurotoxicity (seizures, confusion)
  • Infections (due to suppressed immunity)
  • Increased risk of malignancies (especially lymphomas and skin cancer)
  • Hepatotoxicity (liver dysfunction)
• Long-term Risks:
  • Chronic kidney disease
  • Opportunistic infections
  • Metabolic complications (diabetes, hyperlipidemia)

Patients must report any signs of infection, unusual fatigue, vision changes, or reduced urine output promptly to their

PANGRAF 1.0 Contraindications PANGRAF 1.0

PANGRAF 1.0 should not be used in certain medical conditions due to the risk of serious adverse effects. A careful assessment of risks versus benefits is required before initiating therapy.

• Absolute Contraindications:
  • Known hypersensitivity to Tacrolimus or any of the excipients
  • History of severe allergic reactions to macrolide antibiotics (due to structural similarity)
• Relative Contraindications (Use with caution):
  • Severe hepatic impairment
  • Uncontrolled infections
  • Pregnancy and lactation (use only if clearly needed)
  • Pre-existing kidney disease (due to risk of nephrotoxicity)
  • Uncontrolled hypertension or diabetes

Before prescribing PANGRAF 1.0, healthcare providers should conduct a thorough medical history, including screening for drug allergies and organ function tests.

Storage of PANGRAF 1.0

Proper storage of PANGRAF 1.0 ensures its stability, effectiveness, and safety. As an oral immunosuppressant, it must be handled with care.

• Storage Temperature: Store below 25°C (77°F). Do not refrigerate or freeze.
• Keep Dry: Protect from moisture and humidity. Store in the original packaging.
• Protect from Light: Keep capsules in a tightly closed container, away from direct sunlight.
• Keep Out of Reach of Children: As tacrolimus is a potent immunosuppressant, accidental ingestion by children can be dangerous.
• Do Not Use After Expiry: Always check the expiry date and dispose of any expired or unused medicine properly.

Do not store in the bathroom or near sinks. If you have any questions about proper storage, consult your pharmacist or healthcare provider.