Adulfen Lysine may be available in the countries listed below.
Ibuprofen lysine (a derivative of Ibuprofen) is reported as an ingredient of Adulfen Lysine in the following countries:
International Drug Name Search
Generic Name: ofloxacin ophthalmic (oh FLOX a sin off THAL mik)
Brand Names: Ocuflox
Ofloxacin ophthalmic is an antibiotic.
Ofloxacin ophthalmic is used to treat bacterial infections of the eyes.
Ofloxacin ophthalmic may also be used for purposes other than those listed in this medication guide.
Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.
If you wear contact lenses, ask your doctor if you should wear them during treatment. Ofloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.
Use ofloxacin ophthalmic eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before using the eyedrops.
To apply the eyedrops:
Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.
If you are using ofloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.
Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.
An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.
If you wear contact lenses, ask your doctor if you should wear them during treatment. Ofloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.
Serious side effects are not expected to occur during treatment with this medication.
If you are using ofloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.
More commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling or crusting, a bad taste in your mouth, tearing, or sensitivity to light may occur.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Bacterial Conjunctivitis:
Day 1-2: Instill 1-2 drops in the affected eye(s) every 2-4 hours.
Day 3-7: Instill 1-2 drops in the affected eye(s) 4 times daily.
Usual Adult Dose for Corneal Ulcers:
Day 1-2: Instill 1-2 drops in the affected eye(s) every 30 minutes while awake, and 4 and 6 hours after retiring.
Day 3 through 7 to 9: Instill 1-2 drops in the affected eye(s) every hour while awake.
Day 7 to 9 through treatment completion: Instill 1-2 drops in the affected eye(s) 4 times daily.
Usual Pediatric Dose for Bacterial Conjunctivitis:
1-18 years:
Day 1-2: Instill 1-2 drops in the affected eye(s) every 2-4 hours.
Day 3-7: Instill 1-2 drops in the affected eye(s) 4 times daily.
Usual Pediatric Dose for Corneal Ulcers:
1-18 years:
Day 1-2: Instill 1-2 drops in the affected eye(s) every 30 minutes while awake, and 4 and 6 hours after retiring.
Day 3 through 7 to 9: Instill 1-2 drops in the affected eye(s) every hour while awake.
Day 7 to 9 through treatment completion: Instill 1-2 drops in the affected eye(s) 4 times daily.
Drugs other than those listed here may also interact with ofloxacin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Cacit Vitamine D3 may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Cacit Vitamine D3 in the following countries:
Colecalciferol is reported as an ingredient of Cacit Vitamine D3 in the following countries:
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Tegretol Retard may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Tegretol Retard in the following countries:
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Polividona Yodada may be available in the countries listed below.
Povidone-Iodine is reported as an ingredient of Polividona Yodada in the following countries:
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Alefos may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alefos in the following countries:
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Vitamina B6 may be available in the countries listed below.
Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Vitamina B6 in the following countries:
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Amoxport may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxport in the following countries:
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Adsena may be available in the countries listed below.
Mefenamic Acid is reported as an ingredient of Adsena in the following countries:
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Thiamini hydrochloridum Darnitsa may be available in the countries listed below.
Thiamine hydrochloride (a derivative of Thiamine) is reported as an ingredient of Thiamini hydrochloridum Darnitsa in the following countries:
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Cefotaxima Jet may be available in the countries listed below.
Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Cefotaxima Jet in the following countries:
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Neuroswift may be available in the countries listed below.
Mecobalamin is reported as an ingredient of Neuroswift in the following countries:
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Class: Integrase Inhibitors
Chemical Name: N - [(4 - Fluorophenyl)methyl] - 1,6 - dihydro - 5 - hydroxy - 1 - methyl - 2 - {1 - methyl - 1 - [[(5 - methyl - 1,3,4 - oxadiazol - 2 - yl)carbonyl]amino]ethyl} - 6 - oxo - 4 - pyrimidinecarboxamide monopotassium salt
Molecular Formula: C20H20FKN6O5
CAS Number: 871038-72-1
Brands: Isentress
Antiretroviral; HIV integrase inhibitor.1 2 3 4 5
Treatment of HIV-1 infection in conjunction with other antiretrovirals.1 8 14
Safety and efficacy not established in pediatric patients <16 years of age.1 13
Administer orally1 without regard to food.1 5
Available as raltegravir potassium; dosage expressed in terms of raltegravir.1
If used with rifampin, dosage adjustment of raltegravir is necessary.1
Must be given in conjunction with other antiretrovirals.1
Adolescents ≥16 years of age: 400 mg twice daily.1
Adolescents ≥16 years of age receiving rifampin concomitantly 800 mg twice daily.1
400 mg twice daily.1 5
Adults receiving rifampin: 800 mg twice daily.1
Dosage adjustment not necessary in patients with mild to moderate hepatic impairment;1 5 data not available in patients with severe hepatic impairment.1 (See Hepatic Impairment under Cautions.)
Dosage adjustment not necessary.1 5 Avoid administering drug before dialysis session.1 (See Renal Impairment under Cautions.)
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1
Manufacturer states none known.1
During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii], varicella-zoster virus [VZV]); this may necessitate further evaluation and treatment.1
Concomitant use with drugs that are potent inducers of uridine diphosphate-glucuronosyltransferase (UGT) 1A1 (e.g., rifampin) may result in decreased plasma concentrations of raltegravir.1 (See Interactions and see Dosage and Administration.)
Hypersensitivity reactions (e.g., diffuse rash with fever, facial edema) reported.1 b
Increased serum CK concentrations observed.1
Myopathy and rhabdomyolysis reported rarely; relationship to drug not known.1 Use caution in patients at increased risk of myopathy or rhabdomyolysis, including those receiving concomitant therapy with a drug associated with myopathy or rhabdomyolysis.1
Category C.1
Antiretroviral Pregnancy Registry at 800-258-4263.1
Some experts state that safety and pharmacokinetic data are insufficient to recommend raltegravir in pregnant women.7
Distributed into milk in rats; not known whether distributed into human milk.1
Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 5 7
Safety and efficacy not established in pediatric patients <16 years of age.1 13
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1
Risk for further elevations in hepatic enzyme concentrations in patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.1 (See Hepatic Impairment under Dosage and Administration.)
Not known if removed by dialysis; avoid administering drug before dialysis session.1 (See Renal Impairment under Dosage and Administration.)
Insomnia, headache, nausea, asthenia, fatigue.1
Metabolized by UGT 1A1.1 Does not inhibit UGT 1A1 or UGT 2B7 in vitro.1
Not a substrate for CYP isoenzymes.1 Does not inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A or induce CYP1A2, 2B6, or 3A4.1
Does not inhibit P-glycoprotein-mediated transport.1
Potential pharmacokinetic interactions with drugs that are potent inducers of UGT 1A1 (decreased plasma concentrations of raltegravir)1 5 or inhibitors of UGT 1A1 (increased plasma concentrations of raltegravir).1
Not expected to affect pharmacokinetics of drugs that are substrates for UGT 1A1 or UGT 2B7.1
Pharmacokinetic interactions unlikely with drugs that are substrates for CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A.1
Pharmacokinetic interactions unlikely with drugs that are substrates for P-glycoprotein.1
Drug | Interaction | Comments |
|---|---|---|
Abacavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Amprenavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Anticonvulsants (phenobarbital, phenytoin) | Phenytoin and/or phenobarbital potentially may affect the UGT 1A1 pathway;11 effect on raltegravir pharmacokinetics unknown1 | Concomitant use of phenytoin and/or phenobarbital prohibited in expanded-access program11 |
Antimycobacterials, rifamycins (rifabutin, rifampin, rifapentine) | Rifabutin: Possible decreased raltegravir concentrations5 Rifampin: Decreased peak plasma concentrations and AUC of raltegravir1 5 11 | Rifabutin: Consider possibility of pharmacokinetic interaction if optimal virologic response not achieved5 Rifampin: Dosage adjustment needed of raltegravir; use raltegravir 800 mg twice daily1 Rifapentine: Concomitant use not recommended5 |
Atazanavir | Atazanavir or ritonavir-boosted atazanavir: Increased raltegravir concentrations;1 clinical importance unknown; however, combination of ritonavir-boosted atazanavir and raltegravir reportedly well tolerated1 11 In vitro evidence of additive to synergistic antiretroviral effects1 | Ritonavir-boosted atazanavir: Dosage adjustment of raltegravir not needed1 |
Benzodiazepines (e.g., midazolam) | Raltegravir not expected to affect pharmacokinetics of midazolam 1 10 | |
Delavirdine | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Didanosine | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Efavirenz | Decreased raltegravir concentrations;1 11 clinical importance unknown11 In vitro evidence of additive to synergistic antiretroviral effects1 | Consider possibility of a pharmacokinetic interaction if optimal virologic response not achieved5 |
Enfuvirtide | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Etravirine | Decreased raltegravir concentrations; no change in etravirine concentrations. Clinical importance unknown1 | |
Hormonal contraceptives | Raltegravir not expected to affect pharmacokinetics of hormonal contraceptives1 | |
Indinavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Lamivudine | Raltegravir not observed to have a clinically meaningful effect on pharmacokinetics of lamivudine1 In vitro evidence of additive to synergistic antiretroviral effects1 | |
Lopinavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Methadone | Raltegravir not expected to affect pharmacokinetics of methadone1 | |
Nelfinavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Nevirapine | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Omeprazole | Increased raltegravir concentrations1 | Dosage adjustment not necessary1 |
Ritonavir | Pharmacokinetic interaction with low-dose ritonavir unlikely11 In vitro evidence of additive to synergistic antiretroviral effects1 | Consider possibility of drug interactions between raltegravir and other protease inhibitors (PIs) when low-dose ritonavir is used to boost PI concentrations11 |
Saquinavir | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Stavudine | In vitro evidence of additive to synergistic antiretroviral effects1 | |
Tenofovir | Increased raltegravir concentrations; no change in concentrations of tenofovir1 In vitro evidence of additive to synergistic antiretroviral effects1 | |
Tipranavir | Ritonavir-boosted tipranavir: Decreased raltegravir concentrations; however, no effect on efficacy of raltegravir observed in small study1 | Ritonavir-boosted tipranavir: Dosage adjustment of raltegravir not needed1 Consider possibility of pharmacokinetic interaction if optimal virologic response not achieved5 |
Zidovudine | In vitro evidence of additive to synergistic antiretroviral effects1 |
Absolute bioavailability not established.1
Following oral administration in the fasted state, peak plasma concentrations attained in approximately 3 hours.1
AUC increased by approximately 13% when administered with a moderate-fat meal compared with administration in the fasting state.1
Distributed into milk in rats; not known whether distributed into human milk.1
Not known whether crosses the placenta.1
83%.1
Metabolized mainly by UGT 1A1-mediated glucuronidation in the liver.1 5
Excreted in feces (51%) and urine (32%).1
Not known if removed by dialysis.1
9 hours.1
Moderate hepatic impairment: No clinically important pharmacokinetic differences between patients with moderate hepatic impairment and healthy individuals observed.1
Severe hepatic impairment: Pharmacokinetics not studied.1
Severe renal impairment: No clinically important pharmacokinetic differences between patients with severe renal impairment and healthy individuals observed.1
Pediatric patients: Pharmacokinetics not established.1
20–25°C (may be exposed to 15–30°C).1
Inhibits catalytic activity of HIV-1 integrase, an enzyme that integrates HIV DNA into the host cell genome.1 4
Inhibition of integrase prevents propagation of viral infection.1 4
Active against some strains of HIV-1 resistant to nucleoside reverse transcriptase inhibitors (NRTIs) and PIs.1
Resistant HIV-1 strains have been produced in vitro and have emerged during raltegravir therapy.1 b
Critical nature of compliance with HIV therapy.1 Used in conjunction with other antiretrovirals; do not use for monotherapy.1
Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.1 HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.1
Importance of reading patient information provided by the manufacturer.1
Importance of informing clinician if unusual symptoms (e.g., muscle pain, tenderness, weakness) develop or known symptoms persist or worsen.1
If a dose is missed, administer as soon as it is remembered; however, if a dose is skipped, a double dose should not be taken to make up for the missed dose.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, and any concomitant illnesses (e.g., chronic HBV or HCV).1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablet, film-coated | 400 mg (of raltegravir) | Isentress | Merck |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Isentress 400MG Tablets (MERCK SHARP & DOHME): 60/$994.9 or 180/$2874.45
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Merck. Isentress (raltegravir) tablets prescribing information. Whitehouse Station, NJ; 2009 Jul.
2. Cooper D, Gatell J, Rockstroh J et al. Results of BENCHMRK-1, a phase III study evaluating the efficacy and safety of MK-0518, a novel HIV-1 integrase inhibitor, in patients with triple-class resistant virus. 14th Conference on Retroviruses and Opportunistic Infections, Los Angeles, CA. 2007 Feb 25-28. Abstract 105aLB. From website.
3. Steigbigel R, Kumar P, Eron J et al. Results of BENCHMRK-2, a phase III study evaluating the efficacy and safety of MK-0518, a novel HIV-1 integrase inhibitor, in patients with triple-class resistant virus. 14th Conference on Retroviruses and Opportunistic Infections, Los Angeles, CA. 2007 Feb 25-28. Abstract 105bLB. From website.
4. Grinsztejn B, Nguyen BY, Katlama C et al for Protocol 005 team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007; 369:1261-9. [PubMed 17434401]
5. Panel on Antiretroviral Guidelines for Adults and Adolescents of the Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
6. Hammer SM, Saag MS, Schechter M et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]
7. Perinatal HIV Guidelines Working Group. Public Health Service task force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
8. Markowitz M, Nguyen BY, Gotuzzo E et al. Rapid and durable antiretroviral effect of the HIV-1 integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007; 46:125-33. [PubMed 17721395]
9. Anon. Two new drugs for HIV infection. Med Lett Drugs Ther. 2008; 50:2-4.
10. Iwamoto M, Kassahun K, Troyer MD et al. Lack of a pharmacokinetic effect of raltegravir on midazolam: in vitro/in vivo correlation. J Clin Pharmacol. 2008; 48:209-14. [PubMed 18077730]
11. Correll T, Klibanov OM. Integrase inhibitors: a new treatment option for patients with human immunodeficiency virus infection. Pharmacotherapy. 2008: 28:90-101.
12. Merck, North Wales, Pa. Personal communication.
13. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
14. Steigbigel RT, Cooper DA, Kumar PN et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008; 359:339-54. [PubMed 18650512]
b. Merck, North Wales, PA: Personal communication.
Generic Name: cholecalciferol (vitamin D3) (KOE le kal SIF e role)
Brand Names: D 1000 IU, D3-5, D3-50, Delta D3, Vitamin D3
Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.
Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.
Cholecalciferol may also be used for other purposes not listed in this medication guide.
Before taking cholecalciferol, tell your doctor if you are allergic to any drugs, or if you have heart disease, kidney disease, or an electrolyte imbalance.
Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.
high levels of calcium in your blood (hypercalcemia);
high levels of vitamin D in your body (hypervitaminosis D); or
any condition that makes it hard for your body to absorb nutrients from food (malabsorption).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use cholecalciferol:
heart disease;
kidney disease; or
an electrolyte imbalance.
Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Cholecalciferol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.
Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.
thinking problems, changes in behavior, feeling irritable;
urinating more than usual;
chest pain, feeling short of breath; or
early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking cholecalciferol, tell your doctor if you are taking any of the following medicines:
seizure medication;
cholestyramine (Prevalite, Questran);
colestipol (Colestid);
steroids (prednisone and others);
digoxin (digitalis, Lanoxin); or
a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.
This list is not complete and there may be other drugs that can interact with cholecalciferol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: D3-50 side effects (in more detail)
In the US, Aldex (doxylamine systemic) is a member of the drug class upper respiratory combinations and is used to treat Cough and Nasal Congestion and Sinus Symptoms.
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Albendazole is reported as an ingredient of Aldex in the following countries:
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Doxicrisol may be available in the countries listed below.
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Doxicrisol in the following countries:
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Reisetabletten-1A Pharma may be available in the countries listed below.
Dimenhydrinate is reported as an ingredient of Reisetabletten-1A Pharma in the following countries:
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Granofen may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Fenbendazole is reported as an ingredient of Granofen in the following countries:
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Accupro Comp may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Accupro Comp in the following countries:
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Ranitidine is reported as an ingredient of Ranitidina Prediluida Grifols in the following countries:
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Asotax may be available in the countries listed below.
Paclitaxel is reported as an ingredient of Asotax in the following countries:
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Definition of Campylobacter Gastroenteritis: Campylobacter enteritis is an infection in the small intestine caused by More...
The following drugs and medications are in some way related to, or used in the treatment of Campylobacter Gastroenteritis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
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ISDN Hexal may be available in the countries listed below.
Isosorbide Dinitrate is reported as an ingredient of ISDN Hexal in the following countries:
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In the US, Wydase (hyaluronidase systemic) is a member of the drug class miscellaneous uncategorized agents and is used to treat Extravasation, Hypodermoclysis and Subcutaneous Urography.
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Hyaluronidase is reported as an ingredient of Wydase in the following countries:
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Dobren may be available in the countries listed below.
Sulpiride is reported as an ingredient of Dobren in the following countries:
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Cerezyme is a brand name of imiglucerase, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Cerezyme available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cerezyme. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Trinovum may be available in the countries listed below.
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Ethinylestradiol is reported as an ingredient of Trinovum in the following countries:
Norethisterone is reported as an ingredient of Trinovum in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Hemotrex may be available in the countries listed below.
Tranexamic Acid is reported as an ingredient of Hemotrex in the following countries:
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Tensostad may be available in the countries listed below.
Captopril is reported as an ingredient of Tensostad in the following countries:
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Resyl plus may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Resyl plus in the following countries:
Guaifenesin is reported as an ingredient of Resyl plus in the following countries:
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Tablets and other antibacterial drugs, Doxycycline Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg and 50 mg tablets contain doxycycline monohydrate, USP equivalent to 150 mg, 100 mg, 75 mg or 50 mg of doxycycline for oral administration. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, and titanium dioxide. In addition, doxycycline 50 mg tablets contain: FD&C Blue #1 Aluminum lake and polyethylene glycol, 75 mg tablets contain: D&C Yellow #10 Aluminum lake, FD&C Blue #1 Aluminum lake, FD&C Yellow #6 Aluminum lake and triacetin, 100 mg tablets contain: polyethylene glycol and FD&C Blue #1 Aluminum lake and 150 mg tablets contain: polyethylene glycol. Its molecular weight is 462.46. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.
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.
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values:
| Time (hr): | 0.5 | 1 | 1.5 | 2 | 3 | 4 | 8 | 12 | 24 | 48 | 72 |
| Conc: (mcg/mL) | 1.02 | 2.26 | 2.67 | 3.01 | 3.16 | 3.03 | 2.03 | 1.62 | 0.95 | 0.37 | 0.15 |
| Average Observed Values | |
| Maximum Concentration | 3.61 mcg/mL (± 0.9 sd) |
| Time of Maximum Concentration | 2.60 hrs (± 1.10 sd) |
| Elimination Rate Constant | 0.049 per hr (± 0.030 sd) |
| Half-Life | 16.33 hrs (± 4.53 sd) |
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 1 to 5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function.
Hemodialysis does not alter serum half-life.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative microorganisms. Cross-resistance of these microorganisms to tetracyclines is common.
Doxycycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Aerobic Gram-Positive Microorganisms:
Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:
*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.
Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used to treat streptococcal infections unless the microorganism has been demonstrated to be susceptible.
Aerobic Gram-Negative Microorganisms:
Calymmatobacterium granulomatis
Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC’s). These MIC’s provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC’s should be determined using a standardized procedure. Standardized procedures are based on a dilution method 1,3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline powder. The MIC values should be interpreted according to the following criteria for indicated aerobic microorganisms other than Haemophilus species, Neisseria gonorrhoeae, and Streptococcus pneumoniae:
| MIC (mcg/mL) | Interpretation |
| ≤ 4 | Susceptible (S) |
| 8 | Intermediate (I) |
| ≥ 16 | Resistant (R) |
When testing Haemophilus spp.a
| MIC (mcg/mL) | Interpretation |
| ≤ 2 | Susceptible (S) |
| 4 | Intermediate (I) |
| ≥ 8 | Resistant (R) |
When testing Neisseria gonorrhoeaeb
| MIC (mcg/mL) | Interpretation |
| ≤ 0.25 | Susceptible (S) |
| 0.5 to 1 | Intermediate (I) |
| ≥ 2 | Resistant (R) |
When testing Streptococcus pneumoniaec
| MIC (mcg/mL) | Interpretation |
| ≤ 2 | Susceptible (S) |
| 4 | Intermediate (I) |
| ≥ 8 | Resistant (R) |
a. Interpretative criteria applicable only to tests performed by broth microdilution method using Haemophilus Test Medium (HTM). 1,3
b. Interpretative criteria applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement. 1,3
c. Interpretative criteria applicable only to tests performed by broth microdilution method using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood. 1,3
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard tetracycline powder should provide the following MIC values:
| Microorganism | MIC (mcg/mL) | |
| Enterococcus faecalis | ATCC 29212 | 8 to 32 |
| Escherichia coli | ATCC 25922 | 0.5 to 2 |
| Haemophilus influenzaea | ATCC 49247 | 4 to 32 |
| Neisseria gonorrhoeaeb | ATCC 49226 | 0.25 to 1 |
| Pseudomonas aeruginosa | ATCC 27853 | 8 to 32 |
| Staphylococcus aureus | ATCC 29213 | 0.12 to 1 |
| Streptococcus pneumoniaec | ATCC 49619 | 0.12 to 0.5 |
a. Range applicable only to tests performed by broth microdilution method using Haemophilus Test Medium (HTM). 1,3
b. Range applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement. 1,3
c. Range applicable only to tests performed by broth microdilution method using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood. 1,3
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure 2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg tetracycline or 30 mcg doxycycline to test the susceptibility of microorganisms to doxycycline.
Reports from the laboratory providing results of the standard single-disk susceptibility test with 30 mcg tetracycline-class disk or the 30 mcg doxycycline disk should be interpreted according to the following criteria for indicated aerobic microorganisms other than Haemophilus species, Neisseria gonorrhoeae, and Streptococcus pneumoniae:
| Zone Diameter (mm) | Interpretation | |
| Tetracycline | Doxycycline | |
| ≥ 19 | ≥ 16 | Susceptible (S) |
| 15 to 18 | 13 to 15 | Intermediate (I) |
| ≤ 14 | ≤ 12 | Resistant (R) |
| Zone Diameter (mm) | Interpretation |
| tetracycline | |
| ≥ 29 | Susceptible (S) |
| 26 to 28 | Intermediate (I) |
| ≤ 25 | Resistant (R) |
When testing Neisseria gonorrhoeae b
| Zone Diameter (mm) | Interpretation |
| tetracycline | |
| ≥ 38 | Susceptible (S) |
| 31 to 37 | Intermediate (I) |
| ≤ 30 | Resistant (R) |
Zone diameters ≤ 19 mm may indicate a plasmid-mediated tetracycline-resistant Neisseria gonorrhoeae (TRNG) isolate. These TRNG strains should be confirmed by the dilution test (MIC ≥ 16 mcg/mL).
When testing Streptococcus pneumoniae c
| Zone Diameter (mm) | Interpretation |
| tetracycline | |
| ≥ 23 | Susceptible (S) |
| 19 to 22 | Intermediate (I) |
| ≤ 18 | Resistant (R) |
a. Interpretative criteria applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using Haemophilus Test Medium (HTM). 2,3
b. Interpretative criteria applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using GC agar base with 1% defined growth supplement. 2,3
c. Interpretative criteria applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO 2.2,3
Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for tetracycline or doxycycline, respectively.
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg tetracycline-class disk or the 30 mcg doxycycline disk should provide the following zone diameters in these laboratory test quality control strains:
| Microorganism | Zone Diameter (mm) | ||
| tetracycline | doxycycline | ||
| Escherichia coli | ATCC 25922 | 18 to 25 | 18 to 24 |
| Haemophilus influenzaea | ATCC 49247 | 14 to 22 | -- |
| Neisseria gonorrhoeaeb | ATCC 49226 | 30 to 42 | -- |
| Staphylococcus aureus | ATCC 25923 | 24 to 30 | 23 to 29 |
| Streptococcus pneumoniaec | ATCC 49619 | 27 to 31 | -- |
a. Range applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using Haemophilus Test Medium (HTM). 2,3
b. Range applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using GC agar base with 1% defined growth supplement. 2,3
c. Range applicable only to tests performed by disk diffusion method using a 30 mcg tetracycline-class disk and using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO2.2,3
For anaerobic bacteria, the susceptibility to tetracycline as MIC’s can be determined by standardized test methods.4 The MIC values obtained should be interpreted according to the following criteria:
| MIC (mcg/mL) | Interpretation |
| ≤ 4 | Susceptible (S) |
| 8 | Intermediate (I) |
| ≥ 16 | Resistant (R) |
Interpretation is identical to that stated above for results using dilution techniques.
As with other susceptibility techniques, the use of laboratory control microorganisms is required to control the technical aspects of the laboratory standardized procedures. Standardized tetracycline powder should provide the following MIC values:
| Microorganism | MIC (mcg/mL) | |
| Bacteroides fragilisa | ATCC 25285 | 0.12to 0.5 |
| Bacteroides thetaiotaomicrona | ATCC 29741 | 8to 32 |
a.Range applicable only to tests performed by the reference agar dilution method.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Tablets and other antibacterial drugs, Doxycycline 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 Tablets are indicated for the treatment of the following infections:
Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.
Respiratory tract infections caused by Mycoplasma pneumoniae.
Lymphogranuloma venereum caused by Chlamydia trachomatis.
Psittacosis (omithosis) caused by Chlamydia psittaci.
Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caused by Chlamydia trachomatis.
Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.
Nongonococcal urethritis caused by Ureaplasma urealyticum.
Relapsing fever due to Borrelia recurrentis.
Doxycycline Tablets are also indicated for the treatment of infections caused by the following gram-negative microorganisms:
Chancroid caused by Haemophilus ducreyi.
Plague due to Yersinia pestis (formerly Pasteurella pestis).
Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).
Cholera caused by Vibrio cholerae (formerly Vibrio comma).
Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).
Brucellosis due to Brucella species (in conjunction with streptomycin).
Bartonellosis due to Bartonella bacilliformis.
Granuloma inguinale caused by Calymmatobacterium granulomatis.
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline Tablets are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
Enterobacter aerogenes (formerly Aerobacter aerogenes)
Acinetobacter species (formerly Mima species and Herellea species)
Respiratory tract infections caused by Haemophilus influenzae.
Respiratory tract and urinary tract infections caused by Klebsiella species
Doxycycline Tablets are indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).
Skin and skin structure infections caused by Staphylococcus aureus.
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.
When penicillin is contraindicated, Doxycycline Tablets are an alternative drug in the treatment of the following infections:
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Syphilis caused by Treponema pallidum.
Yaws caused by Treponema pertenue.
Listeriosis due to Listeria monocytogenes.
Vincent’s infection caused by Fusobacterium fusiforme.
Actinomycosis caused by Actinomyces israelii.
Infections caused by Clostridium species.
In acute intestinal amebiasis, Doxycycline Tablets may be a useful adjunct to amebicides.
In severe acne, Doxycycline Tablets may be useful adjunctive therapy.
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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 has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline, 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. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryo toxicity has been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus.
The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
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.
As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued.
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.
Prescribing Doxycycline Tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
All patients taking doxycycline should be advised:
– to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS.)
– to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSEREACTIONS.)
– that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DrugInteractions.)
– that the absorption of tetracyclines is reduced when taking bismuth subsalicylate. (See DrugInteractions.)
– not to use outdated or poorly stored doxycycline.
– that the use of doxycycline might increase the incidence of vaginal candidiasis.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Patients should be counseled that antibacterial drugs, including doxycycline should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Tablets is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Monodox or other antibacterial drugs in the future.
In venereal disease when coexistent syphilis is suspected, a dark-field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.
In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
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.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Long-term studies in animals to evaluate the carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline). Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.
There are no adequate and well-controlled studies on the use of doxycycline in pregnant 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 treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS - the Teratogen Information System - concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk a.
A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. (Sixty-three (0.19%) of the controls and 56 (0.30%) of the cases were treated with doxycycline.) This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases b.
A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age c.
The effect of tetracyclines on labor and delivery is unknown.
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; however, the effects of prolonged exposure to doxycycline in breast milk are unknown d. Because of the potential for adverse reactions in nursing infants from doxycycline, 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 (See WARNINGS).
See WARNINGS and DOSAGE AND ADMINISTRATION sections.
