Minocycline 50mg Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the acceptor site on the mRNA-ribosome complex. This action prevents the addition of new amino acids to the growing peptide chain, leading to bacteriostasis.

Important Side Effects to Report to Your Doctor Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), 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 sunburning
+ 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, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem)
Stomach pain, cramps, or loose, watery, or bloody stools (if you experience these symptoms, call your doctor right away)
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 can cause:
+ Headache
+ Eyesight problems (such as blurred vision, double vision, or loss of vision)
Thyroid cancer (long-term use of this medication has been associated with an increased risk of thyroid cancer; report any of the following symptoms to your doctor:
+ Lasting hoarseness
+ Neck mass
+ Difficulty breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (which can be life-threatening and may affect internal organs)
+ Signs of these reactions 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
- Swollen glands

Other Possible Side Effects

Most people do not experience side effects or only have mild side effects. However, if you experience any of the following side effects, report them to your doctor:

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

Reporting Side Effects

If you have any questions or concerns about side effects, call 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. Be sure to describe the symptoms you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breastfeeding or plan to breastfeed, as 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your 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. Additionally, this medication can increase your susceptibility to sunburn. Exercise caution when exposed to the sun, and inform your doctor if you experience unusual sunburn sensitivity while taking this medication.

In children under 8 years old, this drug may cause a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. If this occurs, the change will be irreversible. Discuss the potential risks and benefits with your doctor, as this medication is typically not recommended for children under 8 years old, except in certain circumstances.

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 concerns about tooth discoloration.

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 this drug may pose a risk to the unborn baby.

• Isotretinoin (and other oral retinoids) - increased risk of pseudotumor cerebri (benign intracranial hypertension)

• Anticoagulants (e.g., Warfarin) - may potentiate anticoagulant effect by decreasing plasma prothrombin activity; monitor INR.
• Penicillins - may interfere with the bactericidal action of penicillin; avoid concomitant use.
• Ergot alkaloids - theoretical increased risk of ergotism (though less documented than with macrolides).

• Antacids containing aluminum, calcium, or magnesium - may decrease minocycline absorption; separate administration by at least 2-3 hours.
• Iron preparations (including multivitamins with iron) - may decrease minocycline absorption; separate administration by at least 2-3 hours.
• Bismuth subsalicylate - may decrease minocycline absorption; separate administration.
• Oral contraceptives - may decrease efficacy of oral contraceptives (though evidence is weak, advise backup contraception).
• Methoxyflurane - increased risk of nephrotoxicity.
• Typhoid vaccine (live, oral) - may decrease therapeutic effect of vaccine; administer minocycline at least 24 hours after last dose of vaccine.

• Not available

• Severe headache
• Blurred vision or vision changes (suggestive of pseudotumor cerebri)
• Dizziness or vertigo
• Nausea, vomiting, diarrhea
• Severe skin rash or blistering (e.g., DRESS syndrome, Stevens-Johnson syndrome)
• Increased sensitivity to sunlight (photosensitivity)
• Yellowing of skin or eyes (jaundice)
• Darkening of skin, nails, or teeth (especially with long-term use)
• Unusual bleeding or bruising
• Joint pain or swelling (lupus-like syndrome)

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Tetracyclines can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.

Minocycline is excreted into breast milk. While the amount is generally low, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution for short-term use, but minocycline's longer half-life and higher lipid solubility may increase infant exposure. Generally, it is recommended to avoid minocycline during breastfeeding or to use an alternative antibiotic if possible, especially for long-term therapy.

Minocycline is contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. Use in children ≥ 8 years should be carefully considered and dosed appropriately.

No specific dose adjustment is generally required based solely on age. However, elderly patients are more likely to have age-related decreases in renal or hepatic function, which may necessitate dose adjustment or closer monitoring. They may also be more susceptible to adverse effects like dizziness.

• Minocycline is unique among tetracyclines for its better absorption in the presence of food/dairy and its higher lipid solubility, allowing better tissue penetration (e.g., CNS, skin).
• It is a common cause of drug-induced lupus erythematosus and DRESS syndrome; monitor for these severe hypersensitivity reactions, especially with long-term use.
• Vestibular side effects (dizziness, vertigo, ataxia) are more common with minocycline than other tetracyclines, especially in women and with higher doses. Advise patients about potential impairment of driving or operating machinery.
• Long-term use can lead to hyperpigmentation of skin, nails, teeth, and sclera, which can be permanent.
• Despite its broad spectrum, resistance is increasing, especially for common pathogens. Culture and susceptibility testing are recommended when possible.

• Doxycycline (another tetracycline, often used for similar indications)
• Erythromycin (macrolide, for acne or certain infections)
• Azithromycin (macrolide)
• Clindamycin (lincosamide, for acne or anaerobic infections)
• Trimethoprim/sulfamethoxazole (for skin infections, UTIs)
• Oral retinoids (e.g., Isotretinoin for severe acne, but contraindicated with minocycline)
• Topical antibiotics (e.g., clindamycin, erythromycin, dapsone for acne)
• Benzoyl peroxide (for acne)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. 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 information about the medication taken, the amount, and the time it occurred.