Minocycline 115mg 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 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
+ 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 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 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 to a darker shade
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

Antibiotic-Related Side Effects

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience:

Stomach pain
Cramps
Loose, watery, or bloody stools

Contact your doctor immediately. Do not treat diarrhea without consulting your doctor.

Other Serious Side Effects

Liver problems: Contact your doctor if you notice dark urine, tiredness, decreased appetite, upset stomach, stomach pain, light-colored stools, vomiting, or yellow skin and eyes.
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, contact your doctor.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur. Seek medical help 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
+ Swollen glands

Common Side Effects

Many people experience no side effects or only minor side effects. However, if you notice any of the following, contact your doctor:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness

Reporting Side Effects

If you have questions about side effects or experience any unusual symptoms, 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 signs and symptoms 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. Note that this medication should not be taken during pregnancy.
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. 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 laboratory 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 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.

Children under 8 years old should not be given this medication. Although less common, tooth discoloration has also been reported in adults, which typically resolves after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

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 a condom, while taking this drug.

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)
• Other retinoids (e.g., acitretin, tretinoin, adapalene, tazarotene) (increased risk of pseudotumor cerebri)

• Anticoagulants (e.g., warfarin) - may potentiate anticoagulant effect
• Penicillins - may interfere with bactericidal action of penicillin
• Ergot alkaloids - theoretical increased risk of ergotism

• Antacids (containing aluminum, calcium, magnesium) - decreased minocycline absorption (separate administration by 2-3 hours)
• Iron preparations - decreased minocycline absorption (separate administration by 2-3 hours)
• Oral contraceptives - may decrease efficacy of oral contraceptives (advise backup method)
• Bismuth subsalicylate - decreased minocycline absorption
• Zinc supplements - decreased minocycline absorption (separate administration by 2-3 hours)

• Headache (especially severe, persistent, or worsening)
• Blurred vision or vision changes
• Dizziness or lightheadedness
• Nausea, vomiting, diarrhea
• Photosensitivity (severe sunburn-like reaction)
• Skin discoloration (blue-gray pigmentation)
• Tooth discoloration (in developing teeth)
• Joint pain or swelling
• Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

Contraindicated during pregnancy. Minocycline can cause permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus if used during tooth development (second and third trimesters). It can also cause reversible inhibition of bone growth.

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant, including permanent tooth discoloration and inhibition of bone growth, use is generally not recommended during breastfeeding. 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.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia. Use in older children and adolescents for approved indications (e.g., acne) should be carefully considered, weighing benefits against risks.

No specific dose adjustment is generally required based on age alone. However, elderly patients are more likely to have decreased renal or hepatic function, which may necessitate dose adjustments or closer monitoring. Monitor for adverse effects, particularly dizziness and gastrointestinal upset.

• Minocycline ER is often preferred for acne due to its once-daily dosing and potentially lower incidence of vestibular side effects compared to immediate-release minocycline.
• Counsel patients extensively on photosensitivity and the importance of sun protection.
• Warn patients about potential for dizziness, especially when initiating therapy or changing positions.
• Educate patients about the rare but serious side effects like pseudotumor cerebri and drug-induced lupus-like syndrome.
• Advise patients that skin, nail, and tooth discoloration can occur with long-term use, which may be permanent.
• Ensure patients understand the importance of separating minocycline from antacids, iron, and calcium supplements.

• Other oral tetracyclines (e.g., doxycycline, tetracycline)
• Other oral antibiotics for acne (e.g., azithromycin, trimethoprim/sulfamethoxazole, clindamycin)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
• Benzoyl peroxide
• Oral isotretinoin (for severe recalcitrant nodular acne)
• Hormonal therapies (e.g., spironolactone, oral contraceptives for 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.