Doxycycline Hyclate 80mg DR Tabs

Doxycycline is a broad-spectrum tetracycline antibiotic. It exerts its antibacterial effect by inhibiting bacterial protein synthesis by binding reversibly to the 30S ribosomal subunit, thereby preventing the binding of aminoacyl tRNA to the mRNA-ribosome complex. At sub-antimicrobial doses (like 80mg DR for certain indications), it also exhibits anti-inflammatory properties by inhibiting matrix metalloproteinases (MMPs), lipase activity, and other inflammatory mediators, which is beneficial in conditions like rosacea and acne.

Serious Side Effects: Seek Medical Help 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, contact your doctor or seek medical attention right away:

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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Chest pain or pressure
Fast heartbeat
Difficulty urinating or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Throat irritation
Trouble swallowing
Muscle or joint pain
Rapid breathing
Flushing
Severe dizziness or fainting
Changes in skin color
Vaginal itching or discharge

Important Antibiotic-Related Side Effect:

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 loose, watery, or bloody stools, contact your doctor immediately. Before treating diarrhea, consult with your doctor.

Rare but Serious Side Effect:

Raised pressure in the brain has been reported with this medication. In most cases, this condition resolves after 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 experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

Diarrhea
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects:

If you have questions about side effects or want to report a side effect, 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 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.

Be aware that this medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and inform your doctor if you experience any unusual sunburn or sensitivity.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, can occur with this medication. These reactions can be life-threatening and may also affect internal organs. 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 birth control methods, 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 can cause permanent tooth discoloration, turning teeth yellow-gray brown. This can also occur in unborn babies if the medication is taken during certain stages of pregnancy. Additionally, tooth problems and affected bone growth have been reported in children taking this medication. If you have concerns, discuss them with your doctor.

Generally, this medication is not recommended for children under 8 years old, but there may be exceptions. Consult with your doctor to determine the best course of treatment.

In some cases, adults have also experienced tooth discoloration, which typically resolves after stopping the medication and undergoing dental cleaning. If you have concerns, discuss them with your doctor.

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

• Isotretinoin (increased risk of pseudotumor cerebri)

• Antacids (containing aluminum, calcium, magnesium): Decreased doxycycline absorption.
• Iron preparations: Decreased doxycycline absorption.
• Bismuth subsalicylate: Decreased doxycycline absorption.
• Oral anticoagulants (e.g., Warfarin): May potentiate anticoagulant effects (monitor INR).
• Penicillins: Tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins (avoid concomitant use for serious infections).
• Oral contraceptives: May decrease efficacy of oral contraceptives (advise backup method).

• Barbiturates (e.g., Phenobarbital): May decrease doxycycline half-life.
• Phenytoin: May decrease doxycycline half-life.
• Carbamazepine: May decrease doxycycline half-life.
• Methotrexate: May increase methotrexate toxicity (monitor for signs of toxicity).

• Not available

• Severe headache
• Blurred vision or vision changes (may indicate pseudotumor cerebri)
• Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
• New or worsening rash, hives, or itching (allergic reaction)
• Severe sunburn or skin sensitivity to light
• Difficulty swallowing or chest pain (esophageal irritation)
• Yellowing of skin or eyes, dark urine (liver problems)

Category D. Doxycycline crosses the placenta. Use is generally contraindicated during pregnancy due to potential for permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth in the fetus.

L3 (Moderate risk). Doxycycline is excreted into breast milk. While absorption by the infant is generally low due to calcium binding 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 usually compatible with breastfeeding, but caution is advised, especially with long-term or repeated use. Monitor infant for diarrhea, candidiasis, and tooth discoloration.

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 weighed against the risks, and only when other agents are not appropriate.

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects, particularly gastrointestinal disturbances and photosensitivity. Monitor renal and hepatic function if pre-existing impairment is present.

• Doxycycline's anti-inflammatory properties at sub-antimicrobial doses (like 40mg DR Oracea, or potentially 80mg DR for certain conditions) make it useful for conditions like rosacea and acne, distinct from its antibiotic effects.
• Always advise patients to take doxycycline with a full glass of water and remain upright for at least 30-60 minutes to prevent esophageal irritation and ulceration.
• Emphasize strict sun protection due to significant photosensitivity risk.
• Counsel patients on avoiding dairy, antacids, and iron supplements around the time of dosing.
• For delayed-release tablets, stress that they should not be crushed, chewed, or broken.

• Other tetracyclines (e.g., minocycline, tetracycline)
• Macrolides (e.g., azithromycin, erythromycin) for certain infections
• Penicillins, cephalosporins, fluoroquinolones (depending on infection type)
• For acne/rosacea: Topical retinoids, topical antibiotics (e.g., metronidazole, azelaic acid), oral isotretinoin (for severe acne), other oral antibiotics (e.g., azithromycin, erythromycin).

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.