Romytop Plus
Romytop Plus Uses, Dosage, Side Effects, Food Interaction and all others data.
Romytop Plus is a lincosamide antibiotic used in the treatment of infections caused by susceptible microorganisms. Romytop Plus is a semisynthetic antibiotic derived from lincomycin. It has antiacne and antibacterial activity. It binds with the 50s subunit of the bacterial ribosome and inhibits the early stage of protein synthesis. It is highly potent against gram positive and anaerobic bacteria.
Microbiology: Aerobic gram-positive cocci, including: Staphylococcus aureus, Staphylococcus epidermidis (penicillinase and non-penicillinase producing strains), Streptococci, Pneumococci. Anaerobic gram-negative bacilli, including: Bacteroides species, Fusobacterium species. Anaerobic gram-positive non-spore forming bacilli, including: Propionibacterium species, Eubacterium species, Actinomyces species. Anaerobic and microaerophilic gram-positive cocci, including: Peptococcus species, Peptostreptococcus species, Microaerophilic streptococci, C. perfringes
Romytop Plus exerts its bacteriostatic effect via inhibition of microbial protein synthesis. Romytop Plus has a relatively short Tmax and half-life necessitating administration every six hours to ensure adequate antibiotic concentrations.
Clostridium difficile associated diarrhea (CDAD) has been observed in patients using clindamycin, ranging in severity from mild diarrhea to fatal colitis and occasionally occurring over two months following cessation of antibiotic therapy. Overgrowth of C. difficile resulting from antibiotic use, along with its production of A and B toxins, contributes to morbidity and mortality in these patients. Because of the associated risks, clindamycin should be reserved for serious infections for which the use of less toxic antimicrobial agents are inappropriate.
Romytop Plus is active against a number of gram-positive aerobic bacteria, as well as both gram-positive and gram-negative anaerobes. Resistance to clindamycin may develop, and is generally the result of base modification within the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete, and may also occur between clindamycin and macrolide antibiotics (e.g. erythromycin) due to similarities in their binding sites.
| Trade Name | Romytop Plus |
| Availability | Prescription only |
| Generic | Clindamycin |
| Clindamycin Other Names | 7-CDL, Clindamicina, Clindamycin, Clindamycine, Clindamycinum |
| Related Drugs | amoxicillin, prednisone, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, ceftriaxone, dexamethasone, levofloxacin |
| Type | Gel |
| Formula | C18H33ClN2O5S |
| Weight | Average: 424.98 Monoisotopic: 424.179871 |
| Protein binding | Clindamycin protein binding is concentration-dependent and ranges from 60-94%. It is bound primarily to alpha-1-acid glycoprotein in the serum. |
| Groups | Approved, Vet approved |
| Therapeutic Class | Miscellaneous Antibiotics |
| Manufacturer | Pharmed Private Limited |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Clindacin lotion is used for the treatment of acne vulgaris.
Other uses of topical Romytop Plus lotion are:
• Skin infections such as erythrasma caused by Corynebacterium minutissimum; rosacea, periorificial dermatitis, folliculitis, stasis, chronic lymphaedema and familial pemphigus.
• Dermal ulcers.
Romytop Plus is also used to associated treatment for these conditions: Abscess, Intra-Abdominal caused by Anaerobic Bacterial Infection, Acne Vulgaris, Babesiosis, Bacterial Endocarditis, Bacterial Vaginosis (BV), Bloodstream Infections caused by Anaerobic Bacterial Infection, Bone and Joint Infections caused by susceptible Staphylococcus, Empyema caused by Anaerobic Bacterial Infection, Endometritis caused by Anaerobic Bacterial Infection, Lung Abscess caused by Anaerobic Bacterial Infection, Malaria caused by Plasmodium falciparum, Mixed Vaginal Infections, Pelvic cellulitis caused by Anaerobic Bacterial Infection, Peritonitis caused by Anaerobic Bacterial Infection, Pneumocystis Jirovecii Pneumonia, Pneumonitis caused by Anaerobic Bacterial Infection, Respiratory Tract Infections (RTI) caused by susceptible Staphylococcus, Respiratory Tract Infections (RTI) caused by susceptible pneumococci, Respiratory Tract Infections (RTI) caused by susceptible streptococci, Skin Structures and Soft Tissue Infections caused by Anaerobic Bacterial Infection, Skin Structures and Soft Tissue Infections caused by susceptible Staphylococcus, Skin Structures and Soft Tissue Infections caused by susceptible streptococci, Toxoplasmosis, Tubo-ovarian abscess caused by Anaerobic Bacterial Infection, Vaginal Candidiasis, Vaginal Mycosis, Chronic Bone and Joint Infections caused by Susceptible infections, Moderate Acne vulgaris, Post-surgical vaginal cuff infection caused by Anaerobic Bacterial Infection, Viridans group streptococci
How Romytop Plus works
Romytop Plus inhibits bacterial protein synthesis by binding to 23S RNA of the 50S subunit of the bacterial ribosome. It impedes both the assembly of the ribosome and the translation process. The molecular mechanism through which this occurs is thought to be due to clindamycin's three-dimensional structure, which closely resembles the 3'-ends of L-Pro-Met-tRNA and deacylated-tRNA during the peptide elongation cycle - in acting as a structural analog of these tRNA molecules, clindamycin impairs peptide chain initiation and may stimulate dissociation of peptidyl-tRNA from bacterial ribosomes.
The mechanism through which topical clindamycin treats acne vulgaris is unclear, but may be related to its activity against Propionibacterium acnes, a bacteria that has been associated with acne.
Dosage
Romytop Plus dosage
At first wash the face or affected area gently with warm water or soap.
Clindacin lotion: When the skin is completely dried (about 30 minutes later) apply a thin film of Clindacin lotion to the entire affected area twice daily. Applied area should not be washed within 3 hours. Noticeable improvement is usually seen after about 6 weeks . However, 8 to 12 weeks of treatment may be required for maximum benefit. Eye, lip or nose contact should be avoided while applying Clindacin lotion.
Romytop Plus Lotion 1%: Clean the face or affected area gently with warm water or soap as recommended by the physician. After the skin is dried, apply a thin film of lotion to the affected areas twice daily, in the morning and in the evening.
Do not wash within three hours after using lotion. The treatment period is usually 6 weeks or as advised by the physician.
However, 8 to 12 weeks of treatment may be required for maximum benefit.
Romytop Plus 2% Vaginal preparation: One applicator full (approximately 5 gm) intravaginally at bedtime for 7 consecutive days. In patients in whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.
Side Effects
Side effects are usually rare. Possible side-effects may includes skin rash, itching, oily skin, dryness, erythema, burning, change in skin color, diarrhea, colitis, GI disturbance etc.
Toxicity
The oral LD50 in mice and rats is 2540 mg/kg and 2190 mg/kg, respectively.
While no cases of overdose have been reported, symptoms are expected to be consistent with the adverse effect profile of clindamycin and may therefore include abdominal pain, nausea, vomiting, and diarrhea. During clinical trials, one 3-year-old child was given a dose of 100 mg/kg daily for 5 days and showed only mild abdominal pain and diarrhea. Activated charcoal may be of value to remove unabsorbed drug, but hemodialysis and peritoneal dialysis are ineffective. General supportive measures are recommended in cases of clindamycin overdose.
Precaution
Clindacin lotion is not for oral, ophthalmic, or Intravaginal use.
Avoid exposure to sunlight and sunlamps. Wear sunscreen daily.
Interaction
Romytop Plus enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Food Interaction
- Take with a full glass of water. Romytop Plus may cause esophageal irritation if the dosage form becomes lodged.
- Take with or without food. Food does not appreciably alter the absorption of clindamycin.
Romytop Plus Drug Interaction
Unknown: diphenhydramine, diphenhydramine, duloxetine, duloxetine, pregabalin, pregabalin, acetaminophen / hydrocodone, acetaminophen / hydrocodone, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, alprazolam, alprazolam, cetirizine, cetirizine
Romytop Plus Disease Interaction
Major: colitis, prematurityModerate: liver disease, renal dysfunction
Volume of Distribution
Romytop Plus is widely distributed in the body, including into bone, but does not distribute into cerebrospinal fluid. The volume of distribution has been variably estimated between 43-74 L.
Elimination Route
Oral bioavailability is nearly complete, at approximately 90%, and peak serum concentrations (Cmax) of, on average, 2.50 µg/mL are reached at 0.75 hours (Tmax). The AUC following an orally administered dose of 300mg was found to be approximately 11 µg•hr/mL. Systemic exposure from the administration of vaginal suppository formulations is 40-fold to 50-fold lower than that observed following parenteral administration and the Cmax observed following administration of vaginal cream formulations was 0.1% of that observed following parenteral administration.
Half Life
The elimination half-life of clindamycin is about 3 hours in adults and 2.5 hours in children. Half-life is increased to approximately 4 hours in the elderly.
Clearance
The plasma clearance of clindamycin is estimated to be 12.3-17.4 L/h, and is reduced in patients with cirrhosis and altered in those with anemia.
Elimination Route
Approximately 10% of clindamycin bioactivity is excreted in the urine and 3.6% in the feces, with the remainder excreted as inactive metabolites.
Pregnancy & Breastfeeding use
Pregnancy: There is no adequate data for safe use in pregnancy. Animal studies showed no adverse effects on the fetus.
Lactation: It is not known that whether Romytop Plus is excreted through breast milk following topical administration. However, Clindacin lotion can be used during lactation with caution.
Contraindication
Romytop Plus is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.
Acute Overdose
Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.
Interaction with other Medicine
Romytop Plus enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Storage Condition
Store between 20-25°C. Do not refrigerate or freeze.
Innovators Monograph
You find simplified version here Romytop Plus
Romytop Plus contains Clindamycin see full prescribing information from innovator Romytop Plus Monograph, Romytop Plus MSDS, Romytop Plus FDA label
FAQ
What is Romytop Plus used for?
Romytop Plus is used to treat a wide variety of bacterial infections. It is an antibiotic used for treatment of a number of bacterial infections, including bone or joint infections, pelvic inflammatory disease, strep throat, pneumonia, middle ear infections, and endocarditis. It can also be used to treat acne, and some cases of methicillin-resistant Staphylococcus aureus.
How does Romytop Plus work?
Romytop Plus works by inhibiting bacterial protein synthesis, which inhibits bacterial growth. It works by slowing or stopping the growth of bacteria.
How safe is Romytop Plus?
Romytop Plus is an effective antibiotic for a variety of serious infections. People can also use Romytop Plus for treating acne. However, there are many possible side effects of Romytop Plus. For this reason, doctors should weigh the benefits and risks before prescribing this antibiotic.
What are the common side effects of Romytop Plus?
Common side effects of Romytop Plus are include:
- nausea
- vomiting
- unpleasant or metallic taste in the mouth
- joint pain
- pain when swallowing
- heartburn
- white patches in the mouth
- thick, white vaginal discharge
- burning, itching, and swelling of the vagina
Is Romytop Plus safe during pregnancy?
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.Use during the first trimester is not recommended unless clearly needed.
Is Romytop Plus safe during pregnancy?
If oral or intravenous Romytop Plus is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.
Can I drink alcohol with Romytop Plus?
It is generally safe to drink alcohol while taking Romytop Plus.
Can I drive after taking Romytop Plus?
Romytop Plus may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.
What time should I take Romytop Plus?
Take Romytop Plus by mouth with or without food, usually 4 times a day (every 6 hours), or as directed by your doctor.
Do I need to take Romytop Plus with food?
Romytop Plus capsules and oral solution may be taken with or without food.
How long does Romytop Plus take to work?
Once you start taking Romytop Plus, you'll likely notice an improvement in your symptoms after a day or two. If your symptoms aren't improving at all or seem to be getting worse after taking Romytop Plus for a few days, follow up with your healthcare provider.
How long does Romytop Plus stay in my system?
After oral administration of Romytop Plus hydrochloride, the average elimination half-life is increased to approximately 4.0 hours in the elderly compared to 3.2 hours in younger adults.
How many times can I take Romytop Plus?
Take Romytop Plus exactly as your doctor tells you to. The usual dose for adults is 150-300 mg four times daily, but the dose may be less than this if it is prescribed for a child.
Can I take Romytop Plus for a long time?
However, to help keep your acne under control, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using this medicine every day for months or even longer in some cases.
Can I just stop taking Romytop Plus?
Do not stop taking Romytop Plus or skip doses if you start to feel better. Doing so could cause your infection to last longer.
Is Romytop Plus safe for kidneys?
Romytop Plus is eliminated by the kidney to a limited extent. Therapy with Romytop Plus should be administered cautiously in patients with severely impaired renal function.
What happen if I stop taking Romytop Plus?
If you stop taking Romytop Plus too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Can Romytop Plus affect my heart?
Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.
Who should not take Romytop Plus?
If you have severe liver disease,blood in the bowel movement, severe renal impairment, a type of allergy you should not take Romytop Plus.
Can I take too much Romytop Plus?
It is important that you do not use this medicine more often than your doctor ordered. It may cause your skin to become too dry or irritated.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
