Minocycline ER 90mg Tablets

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thereby preventing the addition of new amino acids to the growing peptide chain. This action is primarily bacteriostatic. In addition to its antimicrobial effects, minocycline exhibits anti-inflammatory properties, which are thought to contribute to its efficacy in treating inflammatory lesions of acne vulgaris. These anti-inflammatory effects may involve inhibition of neutrophil chemotaxis, reduction of pro-inflammatory cytokines, and inhibition of matrix metalloproteinases.

Important Side Effects to Report to Your Doctor Immediately

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 right away:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ 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:
+ Unable 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 skin, nail, eye, or gum color
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. This condition can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, seek medical attention immediately. Do not treat diarrhea without consulting your doctor.

Other Serious Side Effects

Liver problems: If you experience dark urine, tiredness, decreased appetite, upset stomach, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, seek medical attention right away.
Raised pressure in the brain: If you experience headaches or eyesight problems, such as blurred vision, double vision, or loss of vision, seek medical attention immediately.
Thyroid cancer: If you notice lasting hoarseness, a neck mass, or trouble breathing or swallowing, seek medical attention right away.
Severe skin reactions: If you experience 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, seek medical attention immediately.

Common Side Effects

Not everyone experiences side effects, and many people have only minor side effects. However, if you experience any of the following side effects and they bother you or do not go away, consult your doctor:

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

Reporting Side Effects

If you have questions about side effects or want to report a side effect, call your doctor or the FDA at 1-800-332-1088. You can also report side effects 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. Be sure to describe the allergic reaction you experienced, including any symptoms.
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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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 lab personnel that you are taking this drug.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. When taking this medication, be cautious when exposed to sunlight, as it may increase your susceptibility to sunburn. If you experience easy sunburning while taking this drug, inform your doctor.

In children under 8 years old, this medication may cause a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. 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 it should not be given to children under 8 years old.

Although less common, tooth discoloration has also been reported in adults, which typically reverses after the medication is discontinued and a dental cleaning is performed. Consult your doctor if you have any concerns.

If you are using birth control pills or other hormone-based contraception, be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as condoms, to prevent pregnancy.

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

• Isotretinoin (increased risk of pseudotumor cerebri)

• Anticoagulants (e.g., Warfarin - potentiates anticoagulant effect, monitor INR)
• Penicillins (may interfere with bactericidal action of penicillin, avoid concomitant use)
• Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption, separate administration by at least 2-3 hours)
• Iron preparations (decreased minocycline absorption, separate administration by at least 2-3 hours)
• Oral contraceptives (may decrease efficacy of oral contraceptives, advise backup method)
• Ergot alkaloids (theoretical increased risk of ergotism)

• Digoxin (may increase digoxin levels, monitor)
• Bismuth subsalicylate (decreased minocycline absorption, separate administration)
• Typhoid vaccine, live (tetracyclines may reduce the immunologic response, avoid concurrent use)

• Dizziness
• Vertigo
• Lightheadedness
• Headache
• Blurred vision
• Diplopia
• Nausea
• Vomiting
• Diarrhea
• Photosensitivity (severe sunburn-like reaction)
• Skin rash
• Joint pain or swelling (drug-induced lupus-like syndrome)
• Sore throat
• Fever
• Unusual bleeding or bruising
• Yellowing of skin or eyes (jaundice)

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 enamel hypoplasia if administered during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years). They can also cause reversible inhibition of bone growth.

Minocycline is excreted in breast milk. While the amount absorbed by the infant 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 usually compatible with breastfeeding, but caution is advised. Weigh the benefits of breastfeeding against the potential risks to the infant.

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 adolescents 12 years and older for acne is generally considered acceptable if weighing 45 kg or more.

No specific dose adjustment is generally required based on age alone. However, elderly patients may have reduced renal or hepatic function, which should be monitored. They may also be more susceptible to vestibular side effects (dizziness, vertigo).

• Minocycline ER is often preferred for acne due to its anti-inflammatory properties and once-daily dosing.
• Counsel patients on the importance of taking the medication with a full glass of water and remaining upright for at least 30 minutes to prevent esophageal irritation and ulceration.
• Emphasize sun protection due to photosensitivity.
• Warn patients about potential vestibular side effects (dizziness, lightheadedness, vertigo), which are more common with minocycline than other tetracyclines, especially at higher doses.
• Be aware of the rare but serious adverse effects such as drug-induced lupus-like syndrome, pseudotumor cerebri, and hyperpigmentation (skin, nails, teeth, sclera, scars), which can be irreversible.
• Minocycline can cause blue-gray skin discoloration, particularly in sun-exposed areas or scars, which can be permanent.
• Long-term use (e.g., >6 months) warrants periodic monitoring of liver and renal function.

• Other oral tetracyclines (e.g., Doxycycline, Tetracycline)
• Topical retinoids (e.g., Tretinoin, Adapalene, Tazarotene)
• Topical antibiotics (e.g., Clindamycin, Erythromycin)
• Benzoyl peroxide
• Oral contraceptives (for female patients with acne)
• Isotretinoin (for severe, recalcitrant nodular acne)
• Spironolactone (for hormonal acne in females)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 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. 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 details about the medication taken, the amount, and the time it happened.