Doxycycline Hyclate 75mg DR Tb

Doxycycline is a broad-spectrum 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 A 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 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 liver problems, including:
+ Dark urine
+ Tiredness or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure, or a rapid heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding, or feeling extremely tired or weak
Throat irritation or trouble swallowing
Muscle or joint pain
Rapid breathing or flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge
Diarrhea, especially if it is severe, watery, or bloody (see below for more information on diarrhea)

Important Information About Diarrhea:

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 a life-threatening bowel problem. If you experience stomach pain, cramps, or severe diarrhea (especially if it is watery or bloody), contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Raised Pressure in the Brain:

This medication can cause increased pressure in the brain, which usually resolves once the medication is stopped. However, in some cases, vision loss may occur and may be permanent. If you experience a headache or vision problems, such as blurred vision, double vision, or loss of vision, contact your doctor right away.

Other Side Effects:

Most people do not experience significant side effects or only have mild side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea
Upset stomach or vomiting
* Decreased appetite

Reporting 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. Be sure to describe the allergic reaction and its symptoms.
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 (prescription, over-the-counter, natural products, and vitamins) and health conditions 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 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. If you are on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

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 second infection.

You may be more susceptible to sunburn while taking this medication, so take necessary precautions when exposed to the sun. If you experience unusual sunburn or sensitivity, inform your doctor promptly.

This drug can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions that may affect internal organs. These reactions can be life-threatening. Seek immediate medical attention if you experience symptoms such as 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.

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

In children under 8 years old, this medication may cause permanent tooth discoloration (yellow-gray brown) or other tooth problems. It may also affect bone growth. If you have concerns, discuss them with your doctor. Although this medication is not typically recommended for children under 8, there may be exceptions. Consult with your doctor to determine the best course of treatment.

Tooth discoloration has also been reported in adults, but this condition may be reversible after stopping the medication and undergoing dental cleaning. Consult your doctor if you have concerns.

If you are pregnant or become pregnant while taking this medication, you may be at risk of harming your unborn baby. Inform your doctor immediately if you are pregnant or suspect you may be pregnant.

• Isotretinoin (increased risk of pseudotumor cerebri)
• Acitretin (increased risk of pseudotumor cerebri)

• Antacids (aluminum, calcium, magnesium): Decreased doxycycline absorption
• Iron preparations: Decreased doxycycline absorption
• Bismuth subsalicylate: Decreased doxycycline absorption
• Oral retinoids (e.g., tretinoin, adapalene): Increased risk of pseudotumor cerebri
• Penicillins: May antagonize bactericidal effect of penicillins (avoid concomitant use)
• Warfarin: Potentiation of anticoagulant effect (monitor INR)
• Live bacterial vaccines (e.g., typhoid oral): May reduce vaccine efficacy

• Barbiturates (e.g., phenobarbital): Decreased doxycycline half-life
• Carbamazepine: Decreased doxycycline half-life
• Phenytoin: Decreased doxycycline half-life
• Oral contraceptives: May reduce efficacy of oral contraceptives (use alternative contraception)
• Methotrexate: Increased methotrexate toxicity (rare, but possible)

• Dairy products: Decreased doxycycline absorption (less significant than with other tetracyclines, but still advised to separate)

• Severe diarrhea
• Abdominal cramping
• Fever
• Headache
• Blurred vision
• Diplopia
• Nausea
• Vomiting
• Esophageal irritation/dysphagia
• Skin rash
• Severe sunburn reaction

Category D. Doxycycline crosses the placenta. Use is generally contraindicated during the second and third trimesters due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia in the fetus, as well as reversible inhibition of bone growth. Use in the first trimester should be avoided unless the potential benefit outweighs the risk.

L3 (Moderately safe). Doxycycline is excreted in breast milk in small amounts. While absorption by the infant is generally low due to chelation with calcium in milk, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines compatible with breastfeeding with caution. Monitor infant for diarrhea, candidiasis, or tooth discoloration. Short-term use may be acceptable; prolonged or repeated use should be avoided.

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and enamel hypoplasia, and reversible inhibition of bone growth. In children 8 years and older, it should be used only when other drugs are contraindicated or ineffective, and for the shortest duration possible.

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as photosensitivity or gastrointestinal irritation. Monitor for dehydration and ensure adequate fluid intake to prevent esophageal irritation.

• Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation and ulceration.
• Emphasize sun protection due to significant photosensitivity risk.
• Remind patients to separate doxycycline from antacids, iron, calcium, and dairy products by at least 2-3 hours.
• Doxycycline is a good option for patients with renal impairment as it is primarily eliminated via the GI tract.
• For acne and rosacea, the anti-inflammatory effects of doxycycline at sub-antimicrobial doses (e.g., 20mg BID or 40mg once daily DR) are often utilized, minimizing antibiotic resistance concerns.
• Be aware of the risk of C. difficile-associated diarrhea, especially with prolonged use.

• Minocycline (another tetracycline, often used for acne)
• Azithromycin (macrolide, for respiratory/STI infections)
• Ciprofloxacin (fluoroquinolone, for various infections)
• Amoxicillin/Clavulanate (beta-lactam, for various infections)
• Clindamycin (lincosamide, for skin/soft tissue infections, acne)
• Erythromycin (macrolide, for rosacea, acne, various infections)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.