What happens if I overdose Stericlon 4%?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Stericlon 4% liquid may be harmful if swallowed.
Proper storage of Stericlon 4% liquid:
Store Stericlon 4% liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid excessive heat above 104 degrees F (40 degrees C), and light. Keep Stericlon 4% liquid out of the reach of children and away from pets.
Overdose of Stericlon 4% in details
Ingestion of 1 or 2 ounces of Stericlon 4% gluconate oral rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of Stericlon 4% gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.
Stericlon 4% warnings
Do not use it after the expiry date (EXP) printed on the label. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.
Do not use Stericlon 4% and Cetrimide Irrigation Solution if he packaging is torn or shows signs of tampering.
Wounds may take longer to heal if cetrimide is used regularly. Therefore it is important to use this product as directed by the doctor.
You must tell your doctor if you have allergies to:
* Stericlon 4%
* cetrimide
* any of the ingredients listed at the end of this leaflet
* any other substances, such as foods, preservatives or dyes
If you have an allergic reaction, you may get a skin rash.
Before any Stericlon 4% and Cetrimide Irrigation Solution is used please tell your doctor about any of these things and anything else which you feel is important.
What should I discuss with my healthcare provider before taking Stericlon 4%?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Stericlon 4%, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Stericlon 4% or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Studies on Stericlon 4% have been done only in adult patients, and there is no specific information comparing use of Stericlon 4% in children with use in other age groups.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of Stericlon 4% in the elderly with use in other age groups.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Stericlon 4%. Make sure you tell your doctor if you have any other medical problems, especially:
- Front-tooth fillings (especially those having rough surfaces)—Stericlon 4% may cause staining that, in some cases, may be impossible to remove and may require replacement of the filling
- Gum problems (other)—Use of Stericlon 4% may make other gum problems, such as periodontitis, worse
Stericlon 4% precautions
General
1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Stericlon 4% gluconate oral rinse should not be used as a major indicator of underlying periodontitis.
2. Stericlon 4% gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of Stericlon 4% gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Stericlon 4% gluconate oral rinse users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque.
Stain resulting from use of Stericlon 4% gluconate oral rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis.
Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Stericlon 4% gluconate oral rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
3. Some patients may experience an alteration in taste perception while undergoing treatment with Stericlon 4% gluconate oral rinse. Rare instances of permanent taste alteration following Stericlon 4% gluconate oral rinse use have been reported via post-marketing surveillance.
Pregnancy
Teratogenic EffectsPregnancy category B. Reproduction studies have been performed in rats and rabbits at Stericlon 4% gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stericlon 4% gluconate oral rinse is administered to nursing women.
In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when Stericlon 4% gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 ml (2 capfuls) of Stericlon 4% gluconate oral rinse per day.
Pediatric Use
Clinical effectiveness and safety of Stericlon 4% gluconate oral rinse have not been established in children under the age of 18.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with Stericlon 4% gluconate. The highest doses of Stericlon 4% used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.
References
- DailyMed. "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL: 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).
- DrugBank. "chlorhexidine". http://www.drugbank.ca/drugs/DB00878 (accessed September 17, 2018).
- MeSH. "Disinfectants". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
