What are the possible side effects of Chlorocap?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare - may also occur weeks or months after you stop using Chlorocap
- Bluish tone to the skin
- changes in blood pressure or heart rate
- eating problems
- irregular breathing
- pale skin
- passage of loose green stools
- sore throat and fever
- stomach bloating with or without vomiting
- unusual bleeding or bruising
- unusual tiredness or weakness
Check with your doctor as soon as possible if any of the following side effects occur:
Less common
- Blindness or changes in vision
- burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of Chlorocap
- diarrhea
- fever
- hallucinations
- headache
- mental confusion
- mild depression
- nausea
- stomach pain
- swollen mouth and tongue
- unpleasant taste
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Side effects of Chlorocap in details
1. Blood Dyscrasias
The most serious adverse effect of Chlorocap is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of Chlorocap. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastic or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.
A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of Chlorocap.
An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.
In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.
There have been reports of aplastic anemia attributed to Chlorocap which later terminated in leukemia.
Paroxysmal nocturnal hemoglobinuria has been reported.
2. Gastrointestinal Reactions
Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.
3. Neurotoxic Reactions
Headache, mild depression, mental confusion, and delirium have been described in patients receiving Chlorocap. Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.
4. Hypersensitivity Reactions
Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.
5. "Gray Syndrome"
Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received Chlorocap during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:
a) In most cases therapy with Chlorocap had been instituted within the first 48 hours of life.
b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of Chlorocap.
c) The symptoms appeared in the following order:
(1) abdominal distension with or without emesis;
(2) progressive pallid cyanosis;
(3) vasomotor collapse, frequently accompanied by irregular respiration;
(4) death within a few hours of onset of these symptoms.
d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.
e)Preliminary blood serum level studies revealed unusually high concentrations of Chlorocap (over 90 mcg/mL after repeated doses).
f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.
What is the most important information I should know about Chlorocap?
- Do not exceed the recommended dose or use Chlorocap for longer than prescribed without checking with your doctor.
- Chlorocap is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).
- It is important to use Chlorocap for the full course of treatment. Failure to do so may decrease the effectiveness of Chlorocap and increase the risk that the bacteria will no longer be sensitive to Chlorocap and will not be able to be treated by this or certain other antibiotics in the future.
- Long-term or repeated use of Chlorocap may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
- If symptoms of "gray syndrome" (swelling of the abdomen, pale or blue skin color, vomiting, shock, difficulty breathing, refusal to suck, loose green stools, limp muscles, low temperature) occur in a newborn or infant, contact your doctor. Death may occur within hours of the onset of symptoms. Stopping use of Chlorocap when symptoms first appear increases the chance for a complete recovery.
- Chlorocap may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
- Chlorocap may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
- Diabetes patients - Chlorocap may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Chlorocap with extreme caution in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.
- Use Chlorocap with extreme caution in CHILDREN younger than 10 years of age who have diarrhea or a stomach or bowel infection.
- Use Chlorocap with extreme caution in premature and full-term INFANTS because they may be more sensitive to the effects of Chlorocap, especially the risk of "gray syndrome."
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Chlorocap, discuss with your doctor the benefits and risks of using Chlorocap during pregnancy. Chlorocap should be used with extreme caution during full-term pregnancy and labor because the fetus may experience severe side effects. Chlorocap is excreted in breast milk. Do not breast-feed while taking Chlorocap.
Chlorocap contraindications
Chlorocap Lotion is contraindicated for premature neonates because their skin may be more permeable than full term infants and their liver enzymes may not be sufficiently developed. It is also contraindicated for patients with Norwegian (crusted) scabies due to possible increased absorption. It is also contraindicated for patients with known seizure disorders and for individuals with a known sensitivity to the product or any of its components.
References
- DailyMed. "CHLORAMPHENICOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "chloramphenicol: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Chloramphenicol: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Chlorocap are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Chlorocap. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology