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TOFATHIX-5 Tablets

Tofacitinib Tablets IP 5 mg

PACKING SIZE / TYPE

10x10 Tablets

Summary

Tofacitinib is used alone or in combination with other medicines to reduce signs and symptoms of moderate to severely active rheumatoid arthritis and psoriatic arthritis in adult patients who have had an inadequate response to methotrexate. It is also used in the treatment of ulcerative colitis in adult patients.

Side Effects

Major & minor side effects for Tofacitinib

  • Bladder pain
  • Blurred vision
  • Chills
  • Fast or slow heartbeat
  • Runny Nose
  • Bloating
  • Unsual tiredness or weakness
  • Nausea and vomiting
  • Diarrhea

Usage

What is it prescribed for?

  • Rheumatoid Arthritis

    This medicine is used to relieve pain and swelling associated with rheumatoid arthritis, an autoimmune disease that affects the joints, in adult patients.

  • Psoriatic Arthritis

    This medicine is used to relieve pain, swelling, and formation of scales on the skin associated with psoriatic arthritis (an autoimmune disease affects the joints in patients with psoriasis) in adults.

  • Ulcerative Colitis

    This medicine is used in the treatment of ulcerative colitis for reducing the inflammation (swelling).

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Concerns

Commonly asked questions

  • Onset of action

    The amount of time required for this medicine to show its action is not clinically established.

  • Duration of effect

    The amount of time for which this medicine remains active in the body is not clinically established.

  • Safe with alcohol?

    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

  • Is it habit forming?

    No habit-forming tendencies were reported.

  • Usage in pregnancy?

    This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

  • Usage while breast-feeding?

    This medicine is not recommended for use in breastfeeding women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

When not to use?

Allergy

This medicine is not recommended for use in patients with a known allergy to Tofacitinib or any other inactive ingredients present along with it.

Warnings

Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless necessary. The risks and benefits should be discussed with the doctor before taking this medicine.

General warnings

Driving or operating machinery

Use of this medicine may cause dizziness or blurring of vision in some patients. Hence, it is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating heavy machinery if you experience any such symptoms.

Malignancies

Use of this medicine may cause malignancy or reactivation of a previously treated malignancy. Hence it should be used with caution and frequent clinical monitoring should be performed.

Gastrointestinal perforation

This medicine should be used with extreme caution in patients with or who are at risk of gastrointestinal perforation since it may worsen the patient's condition. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Serious infections

Use of this medicine may affect the immune system making you susceptible to opportunistic infections from a wide variety of pathogens. It is advised to not use this medicine during an active infection. Use of this medicine should be discontinued after consulting the doctor if a serious infection develops.

Use in children

This medicine is not recommended for use in patients below 18 years of age since the safety and efficacy of use are not clinically established.

Lipid elevations

Use of this medicine may increase the levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Therefore it should be used with caution in patients with hyperlipidemia (increased lipid levels in the blood) since it may worsen the patient's condition. Regular monitoring of the lipid levels is recommended while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Non-melanoma skin cancer

This medicine may increase the risk of non-melanoma skin cancer including basal cell, squamous cell, and Merkel cell carcinoma. Frequent skin examinations are recommended while on treatment with this medicine.

Liver impairment

This medicine should be used with caution in patients with liver impairment due to the increased risk of adverse effects. Close monitoring of liver function, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Kidney impairment

This medicine should be used with caution in patients with kidney impairment due to the increased risk of adverse effects. Close monitoring of kidney function, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Dosage

  • Missed Dose

Administer the missed dose as soon as you remember. If it is almost time for the next scheduled dose then the missed dose can be skipped. Do not double the dose to make up for the missed one.

  • Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.

Interactions

All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Interaction with Medicine

Phenobarbital

Live attenuated vaccines and related products

Adalimumab

Clozapine

Disease interactions

Hepatitis B

This medicine should be used with caution in patients with a history of hepatitis B infection since it causes reactivation of the infection. It is recommended to monitor patients with evidence of current or prior hepatitis B infection for signs and symptoms of reactivation. An alternative treatment option should be considered in some cases based on the clinical condition.

Hepatic impairment

This medicine should be used with caution in patients with impaired liver function since it may worsen the condition. Regular monitoring of the liver function tests is recommended while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Tuberculosis

This medicine should be used with extreme caution in patients who have previously been treated for latent or active tuberculosis due to the increased risk of reactivation of the disease. Anti-tuberculosis therapy should be initiated prior to therapy with this medicine if an active infection is confirmed. Appropriate tests should be conducted for the presence of latent tuberculosis in patients.

Infections

Use of this medicine may cause serious and life-threatening infections. Hence, treatment with this medicine should be initiated with extreme caution in patients with a history of recurrent infections, chronic, latent, or localized infections due to the risk of worsening of the patient's condition. While receiving this medicine, any signs and symptoms of an infection such as fever, chills, sore throat, diarrhea, etc. should be reported to the doctor immediately. Replacement with a suitable alternative may be necessary based on the clinical condition.

Hyperlipidemia

This medicine should be used with caution in patients with hyperlipidemia (increased lipids in the blood) since it may worsen the patient's condition. Regular monitoring of the lipid levels is recommended while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Food interactions

Information not available.

Lab interactions

Information not available.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

General Instructions

Take this medicine with or without food. Do not take in larger or smaller amounts than advised/prescribed. Consult the doctor if you experience any undesirable effects. Do not stop taking the medicine without consulting your doctor.

Other Details

  • Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Effect on sleep is not established

  • How it works

This medicine works by blocking the activity of certain enzymes that are involved in the immune cell function.

Legal Status

Approved

Approved

Approved

Approved

Classification

  • Category

Janus Kinase Inhibitor or JAK inhibitors, Antirheumatics, Selective immunosuppressants

Schedule

Schedule H

References

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