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- However, a severe side effect that affects all long-term users of doxycycline is inflammatory bowel disease. In the worst cases, severe inflammation causes the lower digestive tract to close, stopping blood circulation.
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Oct 26, 2020 · Dosage for Doxycycline Hyclate. The usual adult dosage of doxycycline hyclate is 200 mg on ...Preferred Termn (%)Subjects with any AE99 (40.2)Nausea33 (13.4)Vomiting20 (8.1)
stomach pain or tenderness. swelling of the feet or lower legs. swollen, painful, or tender lymph glands in the neck, armpit, or groin. tightness in the chest. unusual tiredness or weakness. unusual weight loss. vomiting. yellow eyes or skin. Some side effects may occur that usually do not need medical attention.
Jul 20, 2021 · The usual dosage of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min.). This percentage excretion may fall as low as
inflammation of the covering of the heart or pericardium. an ulcer in the esophagus. inflammation of the liver called hepatitis. erythema multiforme, a type of allergic skin reaction. a skin ...
Dec 01, 2020 · Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min.).
Jan 15, 2021 · Our Morgidox (doxycycline hyclate capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Use in Specific Populations
- Clinical Pharmacology
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or diseases:
2.1 Usual Dosage and Administration
The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects. Adults: 1. The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. 2. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infect...
2.2 For Prophylaxis of Malaria
For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
2.3 Inhalational Anthrax
Adults: 100 mg, of doxycycline, by mouth, twice-a-day for 60 days. Children: weighing less than 45 kg, 2.2 mg/kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.
Doxycycline hyclate delayed-release tablets USP, 50 mg are yellow, oval tablets debossed with “T 0” on one side and plain on the other side. Each tablet contains specially coated yellow to brown pellets of doxycycline hyclate, USP equivalent to 50 mg of doxycycline. Doxycycline hyclate delayed-release tablets USP, 200 mg are yellow, oval, scored tablets debossed with “T|9” on one side and plain on the other side. Each tablet contains specially coated yellow to brown pellets of doxycycline hyclate, USP equivalent to 200 mg of doxycycline.
5.1 Tooth Development
The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use doxycycline hyclate delayed-release tablets in pediatric patients 8 years of age or less only when the potenti...
Clostridioides Difficile Associated Diarrhea
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate delayed-release tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficilecause increased morbidity...
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
6.1 Clinical Trial Experience
The safety and efficacy of doxycycline hyclate delayed-release tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline hyclate delayed-release tablets 200 mg was given orally once-a-day for 7 days and compared to doxycycline hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatisinfection. Adverse events in the Safety Population were...
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of doxycycline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate a causal relationship to drug exposure. Due to oral doxycycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastroi...
7.1 Anticoagulant Drugs
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
7.3 Antacids and Iron Preparations
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
Teratogenic Effects Risk Summary There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for the treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use durin...
Risk Summary Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated. The effects of prolonged exposure to doxycycline in breast milk are unknown4. Because of the potential for serious adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, takin...
8.4 Pediatric Use
Because of the effects of drugs of the tetracycline-class on tooth development and growth, use doxycycline hyclate delayed-release tablets in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly, when there are no alternative therapies [see Warnings and Precautions (5.1, 5.7) and Dosage and Administration (2.1, 2.3)].
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
Doxycycline Hyclate Delayed-Release Tablets, USP for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate, USP is: The molecular formula is C22H24N2O8 •HCl •½ C2H6O •½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate, USP is 4-(dimethylamino)-1,4,4α,5,5α,6,11,12α-octahydro- 3,5,10,12,12α-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacencarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in...
12.1 Mechanism of Action
Doxycycline is an antibacterial drug [see Microbiology (12.4)].
Following single and multiple-dose administration of doxycycline hyclate delayed-release tablets, 200 mg to adult volunteers, average peak plasma doxycycline concentration (Cmax) was 4.6 mcg/mL and 6.3 mcg/mL, respectively with median tmaxof 3 hours; the corresponding mean plasma concentration values 24 hours after single and multiple doses were 1.5 mcg/mL and 2.3 mcg/mL, respectively. Absorption Doxycycline is virtually completely absorbed after oral administration. Effect of Food The mean C...
Mechanism of Action Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria. Resistance Cross-resistance between tetracyclines is common. Antimicrobial Activity Doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1)]. Gram-Negative Bacteria Acin...