Minocycline 80mg ER 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 ribosomal acceptor site. This action prevents the addition of new amino acids to the growing peptide chain, leading to bacteriostatic effects.

Urgent Side Effects: Seek Medical Help Right Away

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

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 problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ 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 to a darker shade
Mouth irritation or sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal or genital irritation
Vaginal itching or discharge

Antibiotic-Related Side Effects

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately.

Other Serious Side Effects

Liver problems: Contact your doctor right away if you notice dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Raised pressure in the brain: This condition may cause headaches or eyesight problems, such as blurred vision, double vision, or loss of vision. If you experience any of these symptoms, contact your doctor immediately.
Thyroid cancer: Long-term use of this medication has been associated with an increased risk of thyroid cancer. If you notice lasting hoarseness, a neck mass, or difficulty breathing or swallowing, contact your doctor right away.
Severe skin reactions: These reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Common Side Effects

Many people taking this medication may experience mild or no side effects. 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

Reporting Side Effects

If you have questions about side effects or experience any symptoms that concern you, 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. Be sure to describe the allergic reaction you experienced.
If you are currently taking any of the following medications: Acitretin, isotretinoin, or a penicillin.
If you are pregnant or think you might be pregnant. Do not take this medication 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. 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. 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 increase your susceptibility to sunburn. If you experience unusual sunburn or sensitivity, 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 discoloration will not resolve. Discuss this risk with your doctor. This medication is not approved for use in children under 12 years old, so it is essential to consult with your doctor. Furthermore, do not administer this medication to children under 8 years of age.

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, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method.

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) due to increased risk of pseudotumor cerebri (benign intracranial hypertension).

• Anticoagulants (e.g., Warfarin): Tetracyclines can depress plasma prothrombin activity, requiring dosage adjustment of anticoagulants.
• Penicillins: Bacteriostatic drugs like minocycline may interfere with the bactericidal action of penicillins; avoid concomitant use.

• Antacids containing aluminum, calcium, or magnesium, and iron preparations, bismuth subsalicylate, zinc salts: Can form insoluble chelates with minocycline, significantly reducing its absorption. Administer minocycline 2-3 hours before or after these agents.
• Oral Contraceptives: May reduce the effectiveness of oral contraceptives, leading to breakthrough bleeding or unintended pregnancy (though evidence is controversial, caution is advised).
• Ergot alkaloids: Theoretical increased risk of ergotism.
• Methoxyflurane: Concurrent use with tetracyclines has been reported to result in fatal renal toxicity.

• Photosensitivity (severe sunburn-like reaction)
• Dizziness, lightheadedness, vertigo (especially at initiation or with dose changes)
• Gastrointestinal upset (nausea, vomiting, diarrhea)
• Skin discoloration (blue-gray pigmentation, particularly with long-term use)
• Severe headache, blurred vision, diplopia (signs of pseudotumor cerebri)
• Rash, fever, lymphadenopathy, eosinophilia (signs of DRESS syndrome)
• Joint pain, swelling (drug-induced lupus-like syndrome)
• Yellowing of skin or eyes, dark urine (signs of liver problems)

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy due to potential harm to the fetus.

Minocycline is excreted into breast milk. Use is generally not recommended during breastfeeding due to the potential for permanent 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.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth. Use in children 8 years and older should be carefully weighed against these risks.

No specific dose adjustments are generally required based solely on age. However, elderly patients may have reduced renal or hepatic function, which should be considered. Monitor for adverse effects, particularly dizziness and GI upset.

• Minocycline is known for causing vestibular side effects (dizziness, vertigo, ataxia), which are more common with higher doses and in females. These usually resolve with continued therapy or dose reduction.
• Long-term use of minocycline can lead to blue-gray skin, nail, and scleral discoloration, which may be permanent.
• Minocycline has anti-inflammatory properties in addition to its antibacterial effects, which contributes to its efficacy in acne treatment.
• Patients should be advised to report any new or worsening severe headache or vision changes immediately, as these can be signs of pseudotumor cerebri.
• Extended-release formulations are designed to reduce the incidence of GI upset and vestibular side effects compared to immediate-release formulations, by providing more consistent drug levels.

• Other oral tetracyclines (e.g., Doxycycline, Sarecycline) for acne or other infections.
• Macrolide antibiotics (e.g., Azithromycin, Erythromycin) for certain bacterial infections.
• Topical antibiotics (e.g., Clindamycin, Erythromycin) for acne.
• Topical retinoids (e.g., Tretinoin, Adapalene, Tazarotene) for acne.
• Oral retinoids (e.g., Isotretinoin) for severe acne (contraindicated with minocycline).
• Benzoyl peroxide for acne.
• Oral contraceptives for hormonal 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.