Ximino 90mg ER Capsules

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl tRNA to the mRNA-ribosome complex. This leads to bacteriostatic activity. In the treatment of acne, minocycline also exhibits anti-inflammatory properties, likely by inhibiting neutrophil chemotaxis and lipase activity of P. acnes, reducing inflammatory mediators.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Changes in hearing
Joint pain or swelling
Muscle pain or weakness
Ringing in the ears
Seizures
Shortness of breath
Chest pain
Abnormal heartbeat
Swelling
Changes in nail, skin, eye, scar, tooth, or gum color (darkening)
Mouth irritation or mouth sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal or genital irritation
Vaginal itching or discharge
Diarrhea (common with antibiotics), especially if severe, bloody, or watery (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which may cause:
+ Headache
+ Vision problems (blurred vision, double vision, or loss of vision)
Thyroid cancer (rarely reported with long-term use), which may cause:
+ Lasting hoarseness
+ Neck mass
+ Trouble breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and be life-threatening
+ Signs include: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands

Other Possible Side Effects

Most people experience no side effects or only mild side effects when taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Upset stomach or vomiting
Decreased appetite
* Dizziness, drowsiness, tiredness, or weakness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently taking any of the following medications: Acitretin, isotretinoin, or a penicillin.
If you are pregnant or think you may be pregnant. Note that this medication is contraindicated during pregnancy, and you should not take it if you are pregnant.
If you are trying to conceive or father a child.
* If you are breastfeeding or plan to breastfeed. You may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a secondary infection. When taking this medication, be cautious when exposed to sunlight, as it may cause increased sensitivity to sunburn. If you experience unusual sunburn, inform your doctor promptly.

In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the change will be irreversible. Discuss any concerns with your doctor. This medication is not approved for use in children under 12 years old, and its use in children under 8 years old is not recommended.

Although less common, tooth discoloration has also been reported in adults, which typically resolves after discontinuing the medication and undergoing dental cleaning. Consult your doctor if you have any concerns.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, consider using an additional form of birth control, such as condoms.

If you are pregnant or become pregnant while taking this medication, it is crucial to contact your doctor immediately, as it may cause harm to the unborn baby.

• Isotretinoin (risk of pseudotumor cerebri)

• Anticoagulants (e.g., warfarin) - may potentiate anticoagulant effect
• Penicillins - may interfere with bactericidal action of penicillin
• Antacids containing aluminum, calcium, or magnesium - decrease minocycline absorption
• Iron preparations - decrease minocycline absorption
• Oral contraceptives - may decrease efficacy of oral contraceptives (though evidence is limited and controversial)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - theoretical risk of ergotism

• Digoxin - may increase digoxin levels
• Methoxyflurane - concurrent use with tetracyclines may result in fatal renal toxicity
• Typhoid vaccine (live, oral) - may reduce therapeutic effect of vaccine

• Bismuth subsalicylate - may decrease minocycline absorption

• Severe headache
• Blurred vision or vision changes
• Dizziness or lightheadedness
• Nausea, vomiting, or diarrhea
• Skin rash or hives
• Unusual fatigue or weakness
• Yellowing of skin or eyes (jaundice)
• Dark urine or pale stools
• Joint pain or swelling
• Blue-gray skin, nail, or gum discoloration
• Increased sensitivity to sunlight (photosensitivity)

Minocycline is classified as Pregnancy Category D. It can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus if used during pregnancy. It can also cause reversible inhibition of bone growth. Avoid use during pregnancy.

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, including tooth discoloration and inhibition of bone growth, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia. Use in adolescents (12 years and older) for acne is common, but careful consideration of benefits vs. risks is warranted.

No specific dose adjustments are generally required based solely on age. However, elderly patients may have reduced renal or hepatic function, which could necessitate dose adjustments or closer monitoring for adverse effects.

• Minocycline ER is specifically formulated for once-daily dosing, which can improve adherence for acne treatment.
• Counsel patients on the importance of sun protection due to photosensitivity.
• Warn patients about potential for dizziness, especially when starting therapy, and advise caution with driving or operating machinery.
• Educate patients about the rare but serious side effects like pseudotumor cerebri (severe headache, vision changes) and drug-induced lupus-like syndrome (joint pain, fever, rash).
• Minocycline can cause blue-gray skin, nail, or gum discoloration with long-term use, which may be permanent.
• Unlike some other tetracyclines, minocycline's absorption is less affected by food and dairy, but antacids and iron should still be separated.

• Other oral tetracyclines (e.g., doxycycline, sarecycline)
• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Benzoyl peroxide
• Oral isotretinoin (for severe nodular acne)
• Hormonal therapies (e.g., oral contraceptives for females)
• Azelaic acid

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure your safety and the effectiveness of your treatment, never share your medication with others or take medication that has been prescribed to someone else.

It's possible that your medication comes with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide as much information as possible, including the name of the medication taken, the amount, and the time it was taken, to ensure you receive the most effective treatment.