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Solodyn (Minocycline Hydrochloride) - Summary

 
 



SOLODYN SUMMARY

SOLODYN™
(MINOCYCLINE HCl, USP) EXTENDED RELEASE TABLETS

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is a bacteriostatic antimicrobial agent.

SOLODYN™ is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. SOLODYN™ did not demonstrate any effect on non-inflammatory lesions. Safety of SOLODYN™ has not been established beyond 12 weeks of use.

This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SOLODYN™ should be used only as indicated.


See all Solodyn indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Solodyn (Minocycline)

Effect of Minocycline on Lumbar Radicular Neuropathic Pain: A Randomized, Placebo-controlled, Double-blind Clinical Trial with Amitriptyline as a Comparator. [2014]
the treatment of neuropathic pain... CONCLUSIONS:: Although both groups differed from placebo, their effect size was

Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial. [2013]
BACKGROUND: Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available.

High MMP-9 activity levels in fragile X syndrome are lowered by minocycline. [2013]
Fragile X syndrome (FXS) is a neurodevelopmental disorder characterized by lack of the FMR1 protein, FMRP, a translational repressor... The results of this study suggest that, in humans, activity levels of MMP-9 are lowered by minocycline and that, in some cases, changes in MMP-9 activity are positively associated with improvement based on clinical measures.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome. [2013]
CONCLUSIONS: Minocycline treatment for 3 months in children with FXS resulted in

Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment. [2012]
The onset and early course of schizophrenia is associated with subtle loss of grey matter which may be responsible for the evolution and persistence of symptoms such as apathy, emotional blunting, and social withdrawal...

more studies >>

Clinical Trials Related to Solodyn (Minocycline)

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer [Not yet recruiting]
The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness).

Armodafinil is designed to prevent excessive sleepiness.

Minocycline is an antibiotic, which may help to reduce multiple symptoms.

In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil [Recruiting]
The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

Adjunctive Minocycline in Clozapine Treated Schizophrenia Patients [Recruiting]
Schizophrenia is a devastating and costly illness. One-third to one-half of people with schizophrenia do not respond to the most current drugs leaving clozapine as the best alternative for treatment. However, over 60% of people treated with clozapine continue to have persistent symptoms and cognitive impairments. Little data is available to support evidence-based recommendations to guide clinicians in treating these patients. Preliminary data has suggested that adjunct treatment with minocycline may offer robust symptom improvement in patients with schizophrenia, including those taking clozapine. Minocycline has had interesting effects; including suggesting it may have a significant role in treatment of neurologic and psychiatric disorders. Minocycline is currently available generically; its side effects are well-described and minimal. The proposed double-blind treatment study seeks to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology. This knowledge could lead to the more effective treatment of patients with schizophrenia. The research itself may lead to a better understanding of the pathophysiology of positive symptoms and cognitive impairments, which could contribute to improved treatments in the future.

Pilot Study of Minocycline in Huntington's Disease [Active, not recruiting]
This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.

Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS) [Recruiting]
The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome).

A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.

more trials >>

Reports of Suspected Solodyn (Minocycline) Side Effects

Headache (5)Confusional State (4)Pruritus (3)Extrasystoles (3)Dizziness (3)Drug Dispensing Error (3)Blood Glucose Increased (3)Dyspnoea (3)Drug Hypersensitivity (3)Hypersensitivity (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 6 ratings/reviews, Solodyn has an overall score of 4. The effectiveness score is 6.67 and the side effect score is 4.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Solodyn review by 28 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Acne
Dosage & duration:   90mg taken once a day for the period of 30 days
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Solodyn virtually eliminated any acne I had, both on my face and body. It took about a month to see dramatic results, but some results were visible within a few days of starting the medication.
Side effects:   I didn't experience any side effects until about four weeks into treatment, at which time I began breaking out in very mild hives. They were so mild, in fact, that I originally thought they may have been caused by a lotion or cosmetic that had gotten on my skin, or maybe by something I had eaten. The hives would come and go throughout the day, appearing very sparsely on my face, neck, and/or hands. A few days passed, and I realized that they must have been caused by the drug, so I stopped taking it and the hives went away after a day or so. I want to stress that these hives were very mild. I have had allergic reactions to drugs in the past (which may have made be more susceptible this time) and every previous experience I've had with drug-related hives has been much, much worse and possibly life-threatening if not treated. Perhaps that would have been the case with these as well if I had continued taking the drug, but they didn't seem to be particularly alarming, just mildly annoying.
Comments:   I took one pill every morning at the same time each day.

 

Solodyn review by 38 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   acne
Dosage & duration:   45 mg taken once a day for the period of 5 weeks
Other conditions:   None
Other drugs taken:   Yaz
  
Reported Results
Benefits:   While on the drug I did not have any large, red acne lesions.
Side effects:   Lupus-like symptoms that were very severe: light sensitivity extreme fatigue severe joint point iritis (inflammation of the iris of the eye) knee, wrist and finger pain that continues 4 months after stopping the drug iritis flared again 4 months after stopping the drug
Comments:   After I turned 38 my skin changed. It became much oilier and I started having large acne lesions again around my chin. This was especially true before a period or when I was under stress at work. I decided to see a dermatologist as I was sick of the acne. I started Yaz which was alright, as well as Retin-A. This didn't seem to address the larger lesions so my dr. prescribed Solodyn. Looking back now, I think the side-effect started in the first couple weeks, I just didn't identify them as related to the drug. I thought I was suffering from carpal tunnel at work and could explain why my knees hurt so much. I was just about to go to an orthopod when I decided to investigate the Solodyn more. I read about the joint pain and Lupus-like symptoms, stopped the drug immediately and called my dr. to get in and see her. She did some bloodwork and I had a positive ANA blood result (mid-positive, not low). This is one indicator of lupus. My dermatologist was adamant that the symptoms would go away now. I called the office again a week later as I was still having strong side effects and was pretty worried. I got a phone call back that basically said "hello, hypochondriac, you do not have lupus." Then my eye pain started and my eye turned totally red. I went to my GP who referred me to an opthalmologist who diagnosed iritis and I started 7 weeks of drops. She also referred me to a rheumatologist who ran a number of tests and told me she's seen minocycline drugs do this to people a lot and she would never take one or have her children take one - great. That's my saga. Now dealing with another iritis flair up and a lot of pain in my left knee, 4 months after stopping the drug. Please don't take this drug!!!

 

Solodyn review by 38 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   acne
Dosage & duration:   65 mg taken one per day for the period of 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I started this medicine to help my acne, but after a couple of weeks there was no improvement at all. In fact, my skin was worse. I've taken other antibiotics in the past and they were much more effective at clearing up my skin. So I stopped taking the Solodyn.
Side effects:   I haven't taken Solodyn now for a week and I am experiencing very itchy skin, achy joints, and fatigue. The itchy skin is mostly on my scalp and neck. Today I had itchy hives on my leg as well. The joint pain is mostly in my right hand and wrist. It hurts to make a fist and then open my hand back up. I've had allergic reactions to other meds before, but they would stop when I stopped the medicine. For some reason, these nasty side effects are lingering.
Comments:   none

See all Solodyn reviews / ratings >>

Page last updated: 2014-11-30

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